251 Medical Leadership jobs in India
SERM Medical Director
Posted today
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Job Description
Job Purpose
Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting.
Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks.
Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.
Key Responsibilities
Scientific/Medical Knowledge PV Expertise
Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
Leads the safety component of global regulatory submissions.
Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.
Explores positions and alternatives to reach mutually beneficial agreements and solutions.
Cross-functional Matrix team leadership
Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately.
Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues.
Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency.
Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.
Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV).
Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting. Ability to coach and mentor others.
Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees. Has the skillset to interact with confidence, credibility, and influence at all levels of the GSK organisation. In addition, is expected to represent GSK and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
Leads cross-functional process improvement team within GSK.
Thinks tactically/strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements. Contributes to development of long-term strategy for clinical programs.
Regularly contributes innovative ideas to address new issues or improve approaches to existing operations.
Leads inspection readiness and prepared as needed to support audits/inspections.
Excellent communication (verbal, written) and influencing (internally and externally) skills.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Primary medical qualification (MBBS or equivalent) and completion of Specialty training (CCT and fellowship or equivalent level)
Experience, at least, within a Clinical background/setting (2+ years)
Experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
Preferred Qualifications:
PhD/PharmD or MPH in addition to medical degree and registration/certification
Please visit to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
Medical Director - Clinical Oncology
Posted 3 days ago
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Job Description
**Job Description**
**_Objective / Purpose:_**
+ **_Lead and strengthen OTAU R&D capabilities in India_** _to maximize the value for accelerating global innovation and efficiency, in alignment with global OTAU R&D goals._
+ **_Ensure effective oncology operations in India_** _by leveraging local opportunities and overseeing all OTAU Clinical Science activities in India. Be accountable for speed and quality in collaboration with the global OTAU team and if appropriate OTAU-China, OTAU-Japan and other global R&D functions._
+ **_Partner with ISEA and India LOC leaders_** _to enhance enterprise-level efforts for accelerating global clinical trials._
**_Accountabilities:_**
**Lead India R&D Strategy and Execution**
+ Work closely with OTAU GPTs a and Global R&D functions to optimize integrated India development strategy for pipeline assets
+ Monitor overall country performance and support country focused oncology activities e.g. feasibility and site selections to deliver country operational milestones
+ Serve as the internal expert on India's clinical development to inform global development strategy. Collaborate closely with India LOC to execute One Oncology strategy in India including tapping into local expertise and community networks
+ Collaborate and work closely with Oncology GPTs, the Global R&D team and regional teams, as appropriate, for each asset or indications under the remit
+ Engage study investigators to maintain strong interest and focus on Takeda's oncology clinical trials
+ Proactively build and maintain strong investigator networks in India to support current and future trials across Takeda's oncology portfolio in both solid tumors and hematologic malignancies and proactively share with the OTAU and Global teams
+ Build and scale global clinical trial capabilities in India as a key market in collaboration with LOC, Region and Global teams to accelerate Takeda innovation and boost efficiency
**Clinical Development team participation and leadership**
+ Leads the Development Team in India for assigned compounds. In some cases may lead clinical directors or clinical scientist(s) responsible for leading this team with an emphasis on proactively identifying contingencies, risks, and mitigation strategies.
+ Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols in India. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides continual critical and constructive evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
+ Responsible for high impact India specific decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as "go/no go" decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need.
**C. Synopsis / Protocol Development, Study Execution, & Study Interpretation**
+ _Leads Oncology Clinical Science activities in India, including protocol development, study execution, and data interpretation._
+ _Serves as an advisor to the clinical scientists involved in these activities, and be accountable to senior company management for the successful completion of underlying objectives. For the assigned compounds, accountable for the successful completion of projects undertaken - and for pro-active contingency planning / interventions necessary to ensure achievement of related goals._
+ _Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients._
**Trial Medical Monitoring**
+ _Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compounds in conjunction with_ _Pharmacovigilance._
**External Interactions**
+ _Leads KOL and investigator engagement strategies to support development of assigned compounds, and contributes to regulatory strategy in India_
+ _Provides leadership and serves as an advisor to the other clinical physicians and scientists engaged in these activities and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives in India._
**Due Diligence, Business Development and Alliance Projects**
+ _Can be assigned to be responsible for identification and evaluation of potential business development opportunities, conducts due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities, as assigned. As part of a global due diligence team, assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with BD teams_
+ _As assigned, serves as clinical point of contact for ongoing alliance projects and interfaces with partner to achieve Takeda's strategic goals while striving to maintain good working relationship between Takeda and partner. Provides guidance to clinical scientists who are involved in some of these activities._
**Leadership, Task Force Participation, Upper Management Accountability**
+ _Interacts directly with research division based on pertinent clinical and development expertise and with NPP to provide_ _knowledge/understanding_ _of India market environment. Represents clinical science on high impact/priority task forces across the organization or external to the company._
+ _While currently an individual contributor position, the position may evolve or progress to be responsible in hiring, managing, mentoring, motivating, empowering, developing and retaining staff members to support assigned activities. Drives performance management, career development, and team engagement_
**Lead** **India** **Oncology Clinical Science team**
+ _Build, manage/overs_ _ee_ _and engage the_ _OTAU members in India_
+ _Foster a high-performing team culture with a focus on development, well-being, and alignment with OTAU's mission_
**Serving as Country Matter Expert**
+ _Be a strong advocate for the Takeda ONE Oncology and R&D organizations in_ _India_ _in collaboration with_ _India_ _LOC; serve as local bridge for any future opportunities in engaging_ _India_ _innovation ecosystem_
+ _Point for escalation for resolution of complex country related issues & risk and serve as a site escalation point for oncology investigator concerns_
+ **Lead and develop oncology clinical strategies for India according to business needs as assigned**
**_Education & Competencies:_**
**Education, Experience, Knowledge and Skills:**
+ _MD, combined MD/PhD or internationally recognized equivalent_
+ _Clinical Training in Malignant Hematology and/or Medical Oncology preferred_
+ _Minimum 3 to 5 years of clinical research experience in the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned)._
+ _Minimum of 4 to 5 years of people management experience in a healthcare or life sciences setting is preferred._
+ _Proven success in leading global or regional clinical development teams, including responsibility for multi-regional studies. Experience beyond US/EU is a plus._
+ _Experience with NDA/MAA Submission preferred_
+ _Experience and expertise in clinical trial management and support of marketing authorization in India as required._
+ _Demonstrated ability to lead and manage cross-functional medical, scientific and technical teams_
**Skills**
+ _Superior communication, strategic, interpersonal and negotiating skills_
+ _Ability to anticipate challenges and drive proactive problem-solving_
+ _Ability to drive decision-making within matrixed multi-regional teams_
+ _Diplomacy and positive influencing abilities across diverse cultures_
+ _Solid teamwork, organizational, interpersonal, and problem-solving skills; exercises good judgment with respect to Takeda confidential information and strategies_
+ _Fluent business English (oral and written) and strong medical writing capabilities_
**Knowledge**
+ _Deep understanding of oncology therapeutic areas, including mechanisms of action relevant to assigned compounds._
+ _Strong knowledge of global regulatory and compliance requirements, including but not limited to ICH GCP; awareness of local country requirements is essential._
+ _Familiarity with emerging research trends in designated therapeutic area_
**TRAVEL REQUIREMENTS:**
+ _Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required._
+ _Requires approximately 15 - 25% travel._
**Locations**
Mumbai, India
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
Medical Director - Clinical Oncology
Posted today
Job Viewed
Job Description
Description
Lead India R&D Strategy and Execution
Clinical Development team participation and leadership
C. Synopsis / Protocol Development, Study Execution, & Study Interpretation
Trial Medical Monitoring
External Interactions
Due Diligence, Business Development and Alliance Projects
Leadership, Task Force Participation, Upper Management Accountability
Lead India Oncology Clinical Science team
Serving as Country Matter Expert
Education, Experience, Knowledge and Skills:
Skills
Knowledge
TRAVEL REQUIREMENTS:
Locations
Mumbai, IndiaWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeGlobal Safety Associate Medical Director
Posted 3 days ago
Job Viewed
Job Description
**The Global Safety Officer (GSO) for Marketed Products serves 2 roles: 1) safety expert of the assigned marketed product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned marketed products.**
**The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team. The GSO will be assigned as delegate for the TAH as needed and has management of Global Safety Scientists.**
**Key Activities**
**Applicable tasks may vary by product(s) assigned.**
**Product safety profile, benefit-risk evaluation, and risk communication:**
+ Accountable for the Development and maintenance of core reference safety information (e.g Core safety information portions of Core Data Sheet (CDS))
+ Identify relevant data and conduct benefit-risk evaluation
+ Participate in product label process
**Clinical trial safety:**
+ Develop a strategy as needed for preparing and updating safety related portions of the Informed Consent Form and other study related documents for trials conducted post marketing.
+ Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees
+ Perform signal detection activities for developmental products under the direction of the GSO leading the product in development.
**Signal detection, evaluation, and management:**
+ Develop signal detection strategy
+ Evaluate safety signal detection findings, validate signals and determine a need and develop a strategy for further analysis
+ Decide on need for further actions on safety issues and lead cross-functional discussion
+ Documents work as required in the safety information management system
+ Prepares and presents recommendations on safety issues to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body
+ Approves the safety assessment report
+ May search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
+ Documents work as required in the safety information management system
**Risk management and minimization:**
+ Ensure timely preparation, content, and quality of new or updated risk management plan (RMP) document
+ Develop a strategy for safety risk minimization measures globally (including US REMS if applicable)
+ Develop materials for additional risk minimization measures as applicable to role
**Periodic (aggregate) safety reporting:**
+ Ensure timely preparation and quality of periodic reports (e.g., PSUR/PBRER)
+ Review and approve periodic safety reports
**Safety Governance Leadership:**
+ Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g. Facilitates, Chairs, Presents)
**Amgen commercialization process:**
+ Represents and contributes on behalf of Global Patient Safety on Evidence Generation Teams
**Inspection Readiness:**
+ Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
+ Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
+ Partnerships and integration activities
+ Participate in safety agreement development and review process
+ Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement
+ Perform safety due diligence in preparation for partnerships, etc.
+ Participate in integration activities
**Other Amgen processes:**
+ Interact with external stakeholders (e.g., advisory boards) on safety-related topics
+ Prepare for and participate in regulatory agency advisory committees
+ Provide safety input to support legal needs
+ Managerial and supervisory responsibilities
+ Oversees day to day activities of the Global Safety Physician if applicable
+ Ensure staff are compliant with Amgen corporate and departmental training and SOP review
+ Provide training, coaching, mentoring, and development of staff
+ Assist in the recruitment of talented GPS and AMGEN staff
+ Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes
+ Development plans for staff created annually and reviewed quarterly
**Education & Experience (Preferred)**
+ Medical Degree (MBBS or MD) required from an accredited medical school with atleast 8 years of relevant experience .
+ Product safety in the bio/pharmaceutical industry/CRO or regulatory agency
+ Previous management and/or mentoring experience
+ Clinical/medical research experience
408212 SERM Assoc Medical Director
Posted today
Job Viewed
Job Description
Job Description:
Job Purpose:
Provides medical/scientific expertise in the safety evaluation and risk management of key Client assets in clinical development and/or the post-marketing setting.
Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks.
Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs.
Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of Client global assets to ensure Patient Safety globally.
If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.
Key Responsibilities:
Scientific/Medical Knowledge PV Expertise:
Responsible for signal detection and evaluation activities for assigned products.
Drives production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician).
Authors the SERM safety contribution to global regulatory submissions in partnership with the product physician.
May respond to auditors/inspectors requests for information/additional information and completes corrective and preventative actions (CAPAs) within agreed timelines.
Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation.
Makes sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed. Identifies, evaluates, and recommends solutions to problems.
Committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for quality.
Cross-functional Matrix team leadership:
Supports and Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency.
May author/participate in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.
Builds strong collaborative relationships and demonstrates good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes. Ability to coach and mentor others.
Communications (verbal, written) and Influencing (internal PV Governance and External LTs):
Presents complex issues to senior staff members at the Client Senior Governance Committees.
Demonstrates initiative and creativity in performing tasks and responsibilities. Proactively contributes ideas to improve existing operations.
Proactively contributes ideas to improve existing operations.
Participates in process improvement initiatives within GCSP and contributes to advancement of methodology and process by generating new ideas and proposals for implementation.
Possesses effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team. Listens and responds appropriately to the views and feedback of others.
Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major Client products is a core feature of the role.
Effective negotiation, influencing and persuasion to enable others in the matrix to understand own perspective.
Education Requirements:
Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D). Advanced degree preferred
Job Related Experience Requirements:
Substantial experience in pharmacovigilance or drug development.
Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
Experience working in large matrix organizations
Cardiologist- Medical Director (Core Labs)
Posted today
Job Viewed
Job Description
Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
Awards
Associate Medical Safety Director
Posted 3 days ago
Job Viewed
Job Description
Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety's involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.
Essential Functions
- Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
- Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
- Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile
- Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
- Represent safety and clinical data review findings during client meetings
- Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
- Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
- Provide medical oversight for label development, review and change
- Provide medical support and attendance at Data Safety Monitoring Board Meetings
- Attends and contributes medical safety evaluation on Safety Monitoring Committees
- Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
- Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments
- Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract
- Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
- Act as Global Safety Physician or Assistant or Back-up on projects as assigned
- Attend project meetings, medical safety team meetings, and client meetings as requested
- Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
- Provide medical escalation support for medical information projects
- Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
- 24 hour medical support as required on assigned projects
- Maintain awareness of medical-safety-regulatory industry developments
Qualifications
- Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req
- Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
- Knowledge of clinical trials and pharmaceutical research process
- Ability to establish and meet priorities, deadlines, and objectives.
- Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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Associate Medical Safety Director
Posted 3 days ago
Job Viewed
Job Description
Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety's involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.
Essential Functions
- Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
- Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
- Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile
- Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
- Represent safety and clinical data review findings during client meetings
- Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
- Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
- Provide medical oversight for label development, review and change
- Provide medical support and attendance at Data Safety Monitoring Board Meetings
- Attends and contributes medical safety evaluation on Safety Monitoring Committees
- Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
- Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments
- Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract
- Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
- Act as Global Safety Physician or Assistant or Back-up on projects as assigned
- Attend project meetings, medical safety team meetings, and client meetings as requested
- Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
- Provide medical escalation support for medical information projects
- Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
- 24 hour medical support as required on assigned projects
- Maintain awareness of medical-safety-regulatory industry developments
Qualifications
- Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req
- Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
- Knowledge of clinical trials and pharmaceutical research process
- Ability to establish and meet priorities, deadlines, and objectives.
- Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Associate Medical Safety Director
Posted today
Job Viewed
Job Description
Job Overview
Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.
Essential Functions
• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
• Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
• Represent safety and clinical data review findings during client meetings
• Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
• Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
• Provide medical oversight for label development, review and change
• Provide medical support and attendance at Data Safety Monitoring Board Meetings
• Attends and contributes medical safety evaluation on Safety Monitoring Committees
• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
• Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments
• Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract
• Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
• Act as Global Safety Physician or Assistant or Back-up on projects as assigned
• Attend project meetings, medical safety team meetings, and client meetings as requested
• Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
• Provide medical escalation support for medical information projects
• Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
• 24 hour medical support as required on assigned projects
• Maintain awareness of medical-safety-regulatory industry developments
Qualifications
• Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req
• Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
• Knowledge of clinical trials and pharmaceutical research process
• Ability to establish and meet priorities, deadlines, and objectives.
• Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Associate Medical Safety Director
Posted today
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Job Description
Job Overview
Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.
Essential Functions
• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
• Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
• Represent safety and clinical data review findings during client meetings
• Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
• Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
• Provide medical oversight for label development, review and change
• Provide medical support and attendance at Data Safety Monitoring Board Meetings
• Attends and contributes medical safety evaluation on Safety Monitoring Committees
• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
• Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments
• Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract
• Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
• Act as Global Safety Physician or Assistant or Back-up on projects as assigned
• Attend project meetings, medical safety team meetings, and client meetings as requested
• Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
• Provide medical escalation support for medical information projects
• Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
• 24 hour medical support as required on assigned projects
• Maintain awareness of medical-safety-regulatory industry developments
Qualifications
• Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req
• Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
• Knowledge of clinical trials and pharmaceutical research process
• Ability to establish and meet priorities, deadlines, and objectives.
• Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at