46 Drug Safety Associates jobs in India
Drug Safety Associate
Posted 7 days ago
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Job Description
TCS is hiring for PV Drug Safety !
Role: Pharmacovigilance
Work location: Pune
Experience: 1 - 5 years’ relevant experience in Pharmacovigilance
Qualification: Bpharm/ Mpharm/ BHMS/ BAMS/ BDS/ Msc (Biotechnology, Zoology)
Job Description:
*Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code and enter data.
*Be fully competent to perform all steps within the case-handling processing.
*Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures.
*Responsible for follow up procedures.
*Contribute to the development and implementation of new safety-related systems, processes, and procedures within the process.
*Support a performance-driven culture.
Regards,
Manisha Singh
TCS- HR
Drug Safety Physician
Posted 7 days ago
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Job Description
Job Description
Drug Safety Physician
At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization in developed and emerging markets.
We are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk management activities and drive proactive implementation of risk management initiatives to meet global regulatory requirements. The right candidate will have leadership skills, be an excellent communicator with an ability to have oversight over CRO activities and can successfully lead and influence external and internal stakeholders. DSP also serves as a subject matter expert for product-specific safety information.
Responsibilities:
· Contributes to the development & maintenance of product safety profile.
· Involved in all safety surveillance activities, which may include monitoring of adverse event and all other safety information to manage the safety profile of the company products
· Collaborates with, medical monitors and other functional groups in identification, analysis, and reporting of possible safety-related trends or concerns.
· Responsible for the evaluation of safety data from pre-clinical studies, clinical studies, literature and other sources to establish safety profile of company products to manage risk to the patients
· Provides medical input into the identification and utilization of appropriate sources of information and database searches to retrieve relevant data for signal evaluation
· Discuss results of data evaluation with pharmacovigilance safety review team, drug safety committee and/or other key stakeholders
· Provides inputs to literature search strategy and review to effectively determine appropriate and relevant literature for the purposes of safety analysis.
· Responsible for the review of the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) providing expertise to the medical content of the safety specification, risk management plan, risk minimisation measures including the locally implemented risk minimisation measures and drives the implementation of risk minimisation activities in accordance with global regulatory requirements.
· Provides medical input in ensuring that risk minimisation strategies are implemented appropriately in relevant documents such as product reference safety information
· Collaborates with external provider representatives in the preparation and review of aggregate reports having thorough oversight over the critical aspects like summary of safety concerns, benefit risk evaluation, conclusion etc
· Have thorough medical oversight over the external vendors on the medical review of ICSRs
· Provides medical inputs to deliver accurate safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data
· Provides medical inputs in responding to safety questions from regulatory authorities and partners in collaboration with service providers and cross-functional teams
· Review and provides medical inputs to the safety sections of CCDS, local label updates, health hazard analysis, QA trend analysis, device hazard lists, CER etc
· Understands the role of QPPV and contributes to the maintenance of the pharmacovigilance system and process
· Provides inputs to various pharmacovigilance documents like PSMF, SDEA
· Provides input and review for key regulatory or clinical documents (i.e. SMP, protocol, IB, SAE/SUSAR, safety sections of DSUR, ASR, CSR, integrated summaries of safety etc.) related to pharmacovigilance
· Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, signal management, risk management plan preparation and responding to ad-hoc safety questions
· Participates and supports pharmacovigilance audit/inspection preparation and CAPA management
· Participates in internal pharmacovigilance committee meetings as well as joint safety meetings with partners.
· Provides inputs in the preparation/revision of SOPs, working guidance and ensuring pharmacovigilance compliance.
· Meets pharmacovigilance commitments to regulatory authorities with respect to marketing authorization.
· Follows good pharmacovigilance practices (ICH, Eudravigilance, local regulations etc).
· Trains and mentors the team members.
Other Drug Safety Physician responsibilities include:
· Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
· Includes knowledge of case processing, expedited reporting and safety database concepts
· Proactively raises concerns/issues to senior management in a timely and appropriate manner ensures quality and integrity of the issue/event being escalated
· Demonstrates leadership and interacts collaboratively and effectively in team environment (including safety, clinical development, medical affairs,regulatory, commercial, devices) as well as with external stakeholders
· Must be an excellent communicator and have strong negotiation skills with an ability to have oversight over CRO activities
· Strong organisational skills, including capability to prioritise independently with minimal supervision.
Qualifications
· MBBS/PhD/MD with 7+ years of pharmacovigilance experience in the pharmaceutical industry, clinical care setting, or Academia
· Knowledge of the biopharmaceutical industry, drugs and indications with an understanding of applicable guidelines, regulations and best practices for conduct of pharmacovigilance activities.
· High degree of professionalism, maturity, business understanding and passion.
· Strong written and verbal communication skills as well as strong interpersonal skills, with impeccable attention to detail
· Ability to collaborate effectively with internal and external stakeholders at all levels and influence decision-making.
· Must have knowledge of common data processing software like MS office tools (Excel, Power Point, Microsoft Word etc)
Job Location:
Bangalore, India.
Drug Safety Specialist - Japanese
Posted 4 days ago
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Job Description
The below responsibilities vary as per applicable as per the job role.
**General**
+ Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client's guidelines, and SOPs, and Global drug safety regulations
+ Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
+ Assist in development of project specific safety procedures, workflows and templates.
+ Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
+ Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
+ Delegate work as appropriate to Drug Safety Assistants
+ Liaising and collaborating with the relevant function at the client's end to facilitate the delivery of high-quality work
+ Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
+ Mentoring new recruits in the team, if required
+ Archiving the source documents and relevant emails as required
+ Responds to clients/customers in a timely manner
**Case processing**
+ Monitoring of incoming reports from various sources viz mailboxes, Eudravigilance, literature searches etc.
+ Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations
+ Preform a check on overall medical cohesiveness and consistency of the document
+ Compares and analyses data provided by the affiliate with the data available on client application
+ Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool
+ Creates the case on the safety database and performs Data entry into safety database
+ Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs)
+ Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events
+ Ensures MedDRA coding in accordance with "MedDRA Term selection: Points to Consider"
+ Request follow-up and perform query management, as applicable Prepares medically cohesive case narratives based upon the reported information
+ Routes the case to the next workflow state as applicable in the safety database Performs quality checks/validation checks
+ Perform literature searches as per search strategy, performs data entry of valid cases into the safety database
+ Case reconciliation- coordinating activities with Data Management personnel
+ Line listing and tabulation generation for safety reports i.e., periodic safety reports, ad hoc safety reports etc.
+ Supports compliance activities for ICSRs including late case investigation of ICSRs to various Health Authorities and Business Partners to determine the assignable cause for lateness and collection of lateness documentation including corrective actions, where applicable
+ Generation, reporting and reconciliation of compliance metrics in collaboration with internal and external partners and stakeholders, where applicable
**Drug Safety Reporting**
+ Quality control of case reports, line listings, and tabulations Develop Expedited Reporting Procedures
+ Maintain local drug safety reporting requirements
+ Perform registration with relevant authorities for electronic reporting on behalf of sponsor
+ Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
+ Submission of safety reports to investigators via SIS (Safety Information System)
+ Tracking and filing of submission cases as required Unblinding of SUSARs, as required
+ Collect and review metrics for measuring reporting compliance
+ Work with Global PV Information Office for collection and organization of global PV requirements
**Regulatory Affairs**
+ Compares the data received from client with the information present in database for the drug applications to be remediated; identifies and updates any missing information in the database
+ Creates new applications, regulatory events, product detail set, tasks, sequences and references in database based on instructions provided by client Responsible for maintaining and tracking changes in the life cycle of a medicinal product or device such as pharmaceutical strength, packaging, manufacturing sites, storage conditions or shelf life, etc. in the regulatory database per the information received from the client.
+ Creation of variations in the regulatory database to track labeling, quality or administrative changes, creation of references for responses to health authority regarding PSUSA or PBRER, Referrals etc. in the European Union region for National, Centralized, Mutual Recognition and Decentralized procedures.
+ Creation of reports for publishing in order to dispatch the dossier to affiliates or agency (EMA) and generation of marketing authorization status reports from the database for co-ordination of PV activities.
+ Validation the data content with the latest version of SmPC and performing the xEVMPD submissions via EMA Gateway for client's products and tracking the status of submissions and acknowledgement date.
**Literature Search and review**
+ Formulate and maintain the search strategy/strategies in line with parameters provided by the client to enable accurate and exhaustive identification and retrieval of scientific and medical literature articles from the literature database for ad hoc literature requests, regulatory requests and DSUR requests Send the citations retrieved to the requestor in the specified format Records are reviewed, and valid cases are entered into the client database Identification and maintenance of local journals in scope for local literature search
+ Performing Quality Check of the developed/updated search strategies and local journals.
+ Perform periodic review of database thesauri updates and implementation of necessary changes to the search strategies in a timely manner.
+ Interacting with internal or external contacts to resolve issues relatedto literature searches
**Skills:**
+ Sound knowledge of drug safety and the drug development process
+ Knowledge of and ability to interpret and apply global safety regulations
+ Experience in data analysis and evaluation of safety data
+ Good presentation skills
+ Analytical and problem-solving skills
+ Clear understanding of the regulatory submission process
+ Proficient in database/literature searches
+ Excellent interpersonal skills
+ Excellent verbal / written communication skills
+ Excellent organizational and prioritization skills
+ Ability to work collaboratively and effectively in a team environment
+ Client focused approach to work
+ Ability to evaluate data and draw conclusions independently
+ Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
+ Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
**Knowledge and Experience** :
+ Related experience in drug safety/ pharmacovigilance is desirable
+ Good knowledge of medical terminology
+ Excellent communication (written & spoken English + Japanese - JLPT N2 or above).
+ JLPT N2 or higher certification or equivalent
+ Experience with PMDA PV activities
+ Experience working with Japanese-speaking PV case processing teams
**Education:**
+ Degree in life Sciences, Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.), or relevant work experience in Pharmacovigilance.
+ A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Medical Reviewer-Drug Safety Physician
Posted 7 days ago
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We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below:
Job Title: Medical Reviewer – Pharmacovigilance
Location:
Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi
Willingness to relocate to one of the above locations is mandatory.
Education Requirements:
- MBBS and MD (mandatory)
- Candidates without both qualifications will not be considered.
Job Title: Medical Reviewer – Pharmacovigilance
Location:
Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi
Willingness to relocate to one of the above locations is mandatory.
Education Requirements:
- MBBS, MD(mandatory)
- Medical council of India registration ( Mandatory)
Job Description:
As a Medical Reviewer – Pharmacovigilance , you will be responsible for the comprehensive medical review of individual case safety reports (ICSRs) and ensuring compliance with regulatory and client-specific requirements. You will play a critical role in safeguarding patient safety through high-quality medical evaluation and regulatory reporting.
Key Responsibilities:
- Perform medical review of ICSRs for accuracy , medical relevance , and consistency with the source documents and safety database entries, in alignment with client requirements.
- Conduct second-level triaging of non-serious cases to identify any potential serious adverse events (SAEs), as per client-specific conventions.
- Review and validate:
- Suspect product coding
- Event selection and MedDRA coding (current version)
- Grouping/subsuming and event ordering
- Confirm and correct:
- Event coding and classification
- Ranking of events, seriousness criteria, and listedness/expectedness
- Perform comprehensive medical evaluation of adverse event reports including serious/expedited cases and pregnancy-related reports.
- Assess adverse events for seriousness , listedness , and causality , ensuring all medically relevant data from source documents is accurately reflected.
- Review and enhance narratives in compliance with client conventions.
- Provide or verify company pharmacovigilance (PV) comments as needed.
- Initiate appropriate follow-up queries based on the clinical context of the case.
- Identify and escalate potential safety signals or concerns in line with client procedures.
- Ensure completeness and medical soundness of cases before providing final medical sign-off .
- Assess malfunctions and serious injury/death outcomes in relation to combination products.
- Participate in literature surveillance and aggregate report medical review, ensuring compliance with regulatory timelines and SOPs.
- Track and document inconsistencies in data entry and provide feedback for continuous improvement.
- Collaborate closely with cross-functional teams to maintain scientific accuracy , clarity , and regulatory compliance in all case documentation.
- Stay updated with international pharmacovigilance regulations and follow all applicable SOPs , guidelines , and best practices .
- Attend mandatory internal and client-specific trainings to ensure continuous compliance.
Required Skills and Competencies:
- Strong analytical and critical thinking abilities
- High attention to detail and scientific accuracy
- Sound medical judgment and decision-making in line with pharmacovigilance standards
- Proficiency in medical terminology , disease pathology, pharmacology, and therapeutics
- Ability to analyze and interpret adverse event data
- Strong written and verbal communication skills
- Good comprehension and the ability to summarize complex medical data
- Team player with effective interpersonal and collaboration skills
- Familiarity with pharmaceutical industry practices and drug development processes (preferred)
Additional Requirements:
- Willing to relocate to any of the listed office locations.
- Ready to work from the office with hybrid options
- Must possess MBBS and MD degrees (non-negotiable)
EQUAL OPPORTUNITY:
Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
Remote Drug Safety Pharmacovigilance Specialist
Posted 18 days ago
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Job Description
Responsibilities:
- Collect, process, and evaluate adverse event (AE) reports from various sources, including spontaneous reports, clinical trials, and literature.
- Ensure accurate and timely data entry into safety databases, adhering to company standards and regulatory requirements.
- Assess the causality of reported events and perform medical coding (e.g., MedDRA) as per guidelines.
- Prepare aggregate safety reports (e.g., PBRERs, DSURs) in collaboration with medical safety physicians.
- Monitor safety signals and contribute to signal detection activities.
- Communicate with healthcare professionals, patients, and regulatory authorities regarding safety inquiries and reporting obligations.
- Maintain compliance with global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).
- Assist in the development and review of safety-related documents, such as Investigator's Brochures and Risk Management Plans.
- Participate in internal and external audits and inspections related to pharmacovigilance activities.
- Collaborate with cross-functional teams, including regulatory affairs, clinical operations, and medical affairs.
- Contribute to the continuous improvement of pharmacovigilance processes and systems.
- Stay updated on evolving regulatory requirements and industry best practices in drug safety.
- Manage safety database queries and ensure data integrity.
- Support the training of new team members on pharmacovigilance processes.
- Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field. A Master's degree or relevant professional certification (e.g., QPPV, CSP) is a strong asset.
- Minimum of 3 years of experience in drug safety, pharmacovigilance, or clinical safety data management.
- Thorough understanding of global pharmacovigilance regulations and reporting requirements.
- Proficiency with safety databases and pharmacovigilance software.
- Strong knowledge of medical terminology and coding dictionaries (e.g., MedDRA, WHO-ART).
- Excellent analytical, critical thinking, and problem-solving skills.
- Exceptional attention to detail and accuracy in data handling.
- Strong written and verbal communication skills, with the ability to articulate complex safety information clearly.
- Proven ability to work independently, manage time effectively, and meet strict deadlines in a remote work environment.
- Experience with data analysis and report generation.
- Familiarity with clinical trial processes is a plus.
Safety Aggregate Reporting Manager
Posted 7 days ago
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Job Description
Designation : Safety Aggregate Reporting Manager
Skill: Authoring Aggregate reports
Experience: 7+
Location : Across PAN India
Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including but not limited to safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project/client initiatives. Ensure team is following standard best-in-class practices established by the SARA infrastructure
- Serve as a stand-alone global lead for aggregate reporting, signal management.
- Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSURs,
DSURs, PADERs, RMPs, REMS, ACOs, line listings
- and author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
- Act as literature lead, back-up lead, reviewer/QCers to conduct ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data &/or signal detection relevance review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines.
- Act as Signal Management Lead on large and/or complex post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Serve as subject matter expert across projects for complex data mining methodogies and algorithms on internal and external safety datasources. Oversee/set-up and update products' signaling strategies. Oversee/author and/or QC review all types of signal management deliverables.
- Oversee/conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Accountable for full documentation and tracking of signals. At project level, maintain compliance, prepare metrics and KPI, present at audits and inspections.
- In a PV support role, act as functional lead and oversee/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
- Provide training to SARA staff for qualification on SARA deliverables
- May perform quality check of all assigned SARA deliverables
- be responsible for the quality of the final SARA deliverable to client regulatory, IQVIA regulatory reporting (RR), and regulatory authorties.
- Provide consultative guidance to internal and external stakeholders in the for all SARA deliverables.
- Act as mentor to and coach to project team staff and direct line reports.
Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP),
Clinical Trials Manager
Posted today
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Medical Writer (Clinical Trials)
Posted 2 days ago
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Medical Writer
**Business Unit:**
Clinical Research
**Location:**
Sun House, Mumbai
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key responsibilities:**
+ Develop and update process documents, SOPs and trackers for Medical Writing Function
+ Prepare, review and edit clinical trial protocols, investigators brochure (IB), Case Report Form (CRF), Informed Consent Document (ICD) and Patient diaries (if applicable)
+ Prepare, review and edit Clinical Study Report (CSR), executive summary and study-specific logs
+ Ensure all study documents like protocol, ICD, CRF, patient diaries & CSRs are prepared in alignment with ICH-GCP, CDSCO guidelines and all applicable regulatory guidelines
+ Conduct quality check (QC) of protocols, protocol amendments, CRF, ICD, CSR and other relevant documents
+ Lead review cycles of documents with respective stakeholders for timely completion
+ Finalize publication plan for each manuscript in coordination with respective medical affairs personnel
+ Prepare and review manuscripts original research articles, review articles, meta-analyses, consensus / expert opinion, abstracts, posters and other relevant documents, in alignment with IJCME, GPP3 and any other relevant guidelines
+ Work cohesively with internal stakeholders including Clinical research team, Medical Affairs team, business team, regulatory affairs, legal team, compliance team and project specific other functions
+ Strong coordination with external stakeholders including investigators, Key Opinion Leader (KOL) authors, Biostatisticians, Data management team & medical association office bearers
+ Vendor management for Medical writing vendors, in accordance with Sun Pharma policies and procedures
+ Ensure execution of MSAs, project contracts, and invoice management
**Job Requirements**
**Educational Qualification**
MBBS
**Experience**
3-5 years experience in a CRO/Pharma/Biotech organization in Medical Writing for interventional and non-interventional studies
**Additional Skills:**
+ Formal training in Medical Writing will be value add
+ Well versed with IJCME, GPP3, STROBE, CONSORT, STARD, CARE guidelines and PRISMA statement
+ Experience of medical writing for complex publications (e.g. Meta-analysis, consensus, guidelines) with successful outcome will be of added advantage
+ Experience in publications in indexed journals
+ Training in clinical trial methodologies, research design and ICH GCP & publication guidelines
+ Relevant knowledge of Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals
+ Strong academic record with knowledge of research methodologies & publication processes for different type of publications
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Project Manager (Clinical Trials)
Posted 4 days ago
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Project Manager (Clinical Studies)
**Business Unit:**
Clinical Research
**Location:**
Mumbai
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key responsibilities:**
+ Lead a team of clinical research professionals and collaborate with cross-functional stakeholders.
+ Develop and implement project plans, including timelines, milestones, and resource allocation.
+ Define project objectives, deliverables, and success criteria in collaboration with stakeholders.
+ Identify risks and develop mitigation strategies to ensure project success.
+ Allocate resources, assign tasks, and monitor team performance to ensure project goals are met.
+ Develop project budgets, track expenses, and ensure cost-effective utilization of resources.
+ Collaborate with finance and procurement teams to manage contracts, vendor selection, and outsourcing activities.
+ Monitor project progress and resource allocation to ensure efficient utilization and adherence to budgetary guidelines.
+ Ensure adherence to applicable regulatory guidelines, Good Clinical Practice (GCP), and other relevant standards.
+ Oversee the preparation and submission of regulatory documents to ethics committees and regulatory authorities.
+ Implement quality control measures to ensure data integrity, accuracy, and compliance throughout the project
**Job Requirements**
**Educational Qualification**
Bachelor's or Master's degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline, and/or Post-graduate Diploma in Clinical Research.
**Experience**
Relevant experience of 5-10 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
+ Team Management and creating high performing teams
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Clinical Trials Disclosure Mgr
Posted 4 days ago
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Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**Roles & Responsibilities:**
+ Lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidance, and company requirements
+ Work closely with the transparency and disclosure team and with cross functional stakeholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional review and approval, ensure submission readiness, and hand off for timely submission or posting
+ Support trend analysis and continuous improvement initiatives
+ Manage projects, coordinate the work of other staff, and prioritize work in order to meet internal and external deadlines
**Required Skills:**
+ Experience understanding and interpreting data/information and its practical application
+ Working experience with redaction/anonymization of clinical trial documents e.g. for EU CTR, HC-PRCI
+ Working experience with disclosures on public registries e.g. ClinicalTrials.gov
+ Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
+ Good communication skills including excellent spoken and written English
+ Ability to follow controlled processes
+ Leadership skills, including ability to teach, negotiate and influence
+ Project management skills, including ability to prioritize work in order to meet required deadlines
+ Problem solving ability
+ Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
**Basic Qualifications:**
+ Graduate degree and 2 years of relevant work experience in the pharmaceutical industry
OR
+ Bachelor's degree, and 4 years relevant work experience in the pharmaceutical industry
+ Minimum of 2 years experience in preparation of regulatory documents for public disclosure
+ Familiarity with international regulations, guidance and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.