29 Clinical Advisor jobs in India

Medical Advisor/Senior Medical Advisor

Mumbai, Maharashtra Alkem Laboratories Ltd.

Posted 5 days ago

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Job Description

About Alkem:


Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally over 50 countries. We have consistently been ranked amongst the five pharmaceutical companies in India. Our portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O, which feature amongst the top 50 pharmaceutical brands in India.


Job Purpose:


  • To actively contribute to the organization/division by taking responsibility for the scientific, technical and ethical soundness of all policies, statements and endeavors.
  • To support the division medically in all activities related to the portfolio and provide high quality and timely service to internal and external stake holders.


Responsibilities:


  • To actively support development of promotion of allocated portfolio under supervision from the Line manager or the mentor, provide strategic inputs and support towards creation of marketing/brand plans/medical development plans, and towards design and execution of medical-marketing programs/clinical programs, including initiatives to enhance access to medicines
  • Under supervision from the Line manager or mentor, create/review promotional, training, and Continuing Medical Education (CME) material in compliance with relevant industry codes and medical correctness
  • In consultation with the Line manager or mentor, participate/facilitate/conduct customized promotional/educational interactions with Key Opinion Leaders (KOLs). These interactions include, but are not limited to, customer launch meetings, advisory boards, CME programs, scientific symposia, institutional presentations, medical projects and studies
  • In consultation with concerned stakeholders plan research projects and develop / review / approve protocol synopsis/final protocols/supporting documents per need
  • Provide useful, timely, accurate, and balanced medical information to internal (sales staff) and external (HCPs) customers, in adherence to relevant SOPs/policies
  • Impart medical training to new sales staff on basic sciences/ TAs/assigned products. Provide refresher training to sales staff through ongoing training initiatives. Provide pre-launch and launch training to sales staff for new products
  • Support New Product Evaluation (NPE), Marketing, and Business Development colleagues with medical evaluation and recommendations on commercial opportunities with new products. Support organization efforts at developing local formulations/line extensions through literature search/recommendations
  • Support regulatory team by means of writing/revising/reviewing labeling documents for products as per relevant SOPs
  • Support Pharmacovigilance activities by documentation and reporting of Adverse Events in a timely manner.


Qualification : MBBS & MD Pharmacology (Mandatory)


Experience : 1 to 4 years of experience in medico marketing

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Medical Advisor

Mumbai, Maharashtra Abbott

Posted today

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Job Description

MAIN PURPOSE OF ROLE
Experienced professional individual contributor that works under limited supervision.
Applies subject matter knowledge in the area of Medical Affairs.
Requires capacity to apply skills/knowledge within the context of specific needs or requirements.
MAIN RESPONSIBILITIES
- As the Experienced professional in the Medical Affairs Sub-Function, possesses well developed skills
in overseeing the direction, planning, execution, clinical trials/research and the data collection
activities.
- Contributes to implementation of clinical protocols, and facilitates completion of final reports.
- Recruits clinical investigators and negotiates study design and costs.
- Responsible for directing human clinical trials, phases III & IV for company products under
development.
- Participates in adverse event reporting and safety responsibilities monitoring.
- Coordinates and provides reporting information for reports submitted to the regulatory agencies.
- Monitors adherence to protocols and determines study completion.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
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Medical Advisor

Sun Pharmaceuticals, Inc

Posted 2 days ago

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Job Description

**Job Title:**
Medical Advisor
**Business Unit:**
Medical Services
**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:**
+ Core scientific member of cross-functional franchise team and a disease area expert, responsible for scientific enablement of respective business cluster
+ Conceptualization and project management of wide range of medical activities that are aligned to the respective franchise strategy like:
+ New Product Ideation
+ New Product Evaluation
+ Therapeutic rationale & relevant Medical support for regulatory submissions
+ Preparation of SEC presentations & defense in SEC meeting
+ Pre-launch & launch preparations including product monograph, training manuals, training & CME slides
+ Franchise Medical Education programs
+ Promotional and non-promotional material review & approval
+ Answering queries
+ Marketing and Sales training
+ Real World Clinical Research and Publications Planning and Execution
+ Advisory board meetings
+ Developing Insight driven Medical Plans
+ Interaction & Engagement of identified Key Opinion leaders in a peer-to-peer capacity through medical affairs activities, in alignment with the overall strategic plan to shape disease areas of interest
+ A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, obtain insights into patients treatment trends and insights in the disease areas of interest and to be considered a trusted scientific counterpart
+ Responsible for identifying knowledge gaps, practice gaps and data gaps and provide recommendations for devising medical & product education programs, evidence generation and special projects
+ Ability to convert insights on disease trends and treatment patterns from KOLs into viable and formidable solutions to shape the therapeutic areas of interest
+ Devise optimal training plan to ensure flow of latest medical developments in the given to sales & marketing team
+ Jointly responsible with marketing teams to support optimal patient outcomes through communication of data, information, and insights to shape disease areas of interest
+ Represent the organization in various internal & external scientific platforms
+ Collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute
+ Receiving and processing scientific information requests received from physicians & internal stakeholders
+ Ability to handle complex questions from health care professionals related to company products or disease area to satisfaction
+ Responsible for ensuring that all promotional materials are approved within stipulated timelines and in alignment with company approval process
+ Conduct of robust medical evaluation of new products through thorough desk research and interactions with KOLs
**Travel Estimate**
Less than 1 week in a month
**Job Requirements**
**Educational Qualification**
MD Pharmacology
**Experience**
1-3 years working experience in the pharmaceutical industry or research company in a capacity of HO Medical Advisor or Sr. Medical Advisor
+ Training in medical writing, clinical trial methodologies, research design and ICH GCP will be added advantage
+ Must have working knowledge of Indian regulations pertaining to Health care professionals interactions (MCI code of ethics for doctors & UCPMP Code for Pharma) and Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals
+ Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data
+ Strategic mindset with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer capacity
+ Experience with complex business environments preferred
+ Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and award
**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.
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Medical Advisor

Ahmedabad, Gujarat Right Advisors Pvt. Ltd.

Posted 23 days ago

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Job Description

full-time

Job Description- Medical Advisor- Ahmedabad

The Medical Advisor will provide scientific and clinical expertise, focusing on the cardiovascular therapeutic area. This role will support the development of medical strategies, assist in the clinical development process, and engage with both internal and external stakeholders. The successful candidate will report directly to the GM - Medical Affairs and work as an individual contributor.

Key Responsibilities:

  • Medical Expertise and Support:
  • Provide scientific and medical support to internal teams (e.g., regulatory, marketing, and sales) on cardiovascular-related products and clinical data.
  • Review and approve promotional and scientific content to ensure medical accuracy and compliance.
  • Respond to medical queries from internal and external stakeholders, ensuring evidence-based and scientifically accurate information.
  • Clinical Development:
  • Collaborate with the clinical development team in cardiovascular trials, offering input on study design, data analysis, and interpretation.
  • Assist in preparing clinical study reports, publications, and other medical documents as required.
  • KOL and External Engagement:
  • Build and maintain relationships with key opinion leaders (KOLs) and healthcare professionals in the cardiovascular field.
  • Support the organization of scientific meetings, advisory boards, and conferences.
  • Medical Strategy and Communication:
  • Contribute to the development and execution of medical affairs strategies aligned with business goals.
  • Provide support for regulatory submissions and ensure effective communication of clinical data.
  • Training and Development:
  • Conduct training sessions for internal teams, especially on the cardiovascular therapy area and product-related information.
  • Share insights from scientific literature and research findings with cross-functional teams.


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Medical Advisor

Ahmedabad, Gujarat Right Advisors Pvt. Ltd.

Posted 23 days ago

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Job Description

full-time

Company :  Intas Pharma

Interview Venue:

Head Office

Company Profile: Client is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company. It is committed to challenging the unmet medical and societal needs through a comprehensive pharmaceutical value chain spanning across the world.


Designation:  Medical Advisor

Location:  Ahmedabad

Remote Work:  No

Employment details

Employment Type:  Full Time

Experience:  3.0 Year To  10.0 Year

CTC Salary:  15.00 LPA To  26.00 LPA

Functional Area:  Pharma / Biotech / Healthcare / Medical / R&D

Industry:  Pharma/Biotech/Clinical Research

Qualification:

  • Education:
  • MBBS and MD in Pharmacology (or equivalent medical qualifications).
  • Experience:
  • 3-4 years of experience in Medical Affairs, Clinical Research, or related fields in the pharmaceutical industry, particularly in the cardiovascular therapy area.
  • Prior experience in interacting with KOLs and contributing to clinical trial development is highly preferred.


Job Description

Description:Job Description- Medical Advisor- Ahmedabad

The Medical Advisor will provide scientific and clinical expertise, focusing on the cardiovascular therapeutic area. This role will support the development of medical strategies, assist in the clinical development process, and engage with both internal and external stakeholders. The successful candidate will report directly to the GM - Medical Affairs and work as an individual contributor.

Key Responsibilities:

  • Medical Expertise and Support:
  • Provide scientific and medical support to internal teams (e.g., regulatory, marketing, and sales) on cardiovascular-related products and clinical data.
  • Review and approve promotional and scientific content to ensure medical accuracy and compliance.
  • Respond to medical queries from internal and external stakeholders, ensuring evidence-based and scientifically accurate information.
  • Clinical Development:
  • Collaborate with the clinical development team in cardiovascular trials, offering input on study design, data analysis, and interpretation.
  • Assist in preparing clinical study reports, publications, and other medical documents as required.
  • KOL and External Engagement:
  • Build and maintain relationships with key opinion leaders (KOLs) and healthcare professionals in the cardiovascular field.
  • Support the organization of scientific meetings, advisory boards, and conferences.
  • Medical Strategy and Communication:
  • Contribute to the development and execution of medical affairs strategies aligned with business goals.
  • Provide support for regulatory submissions and ensure effective communication of clinical data.
  • Training and Development:
  • Conduct training sessions for internal teams, especially on the cardiovascular therapy area and product-related information.
  • Share insights from scientific literature and research findings with cross-functional teams.

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Regional Medical Advisor (RMA)

Sun Pharmaceuticals, Inc

Posted today

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Job Description

**YOUR TASKS AND RESPONSIBILITIES:**
+ Primary scientific face of the organization to Key Opinion Leaders (KOLs) & physicians for a given therapy area
+ Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis
+ Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan
+ Responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects
+ A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart
+ Jointly responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals
+ Representing the organization in various internal & external scientific platforms
+ Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams
+ Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan
+ Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction
+ Receiving and processing scientific information requests received from physicians
+ Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines
+ Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field
+ Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute
**WHO YOU ARE:**
+ Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity
+ Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data
+ Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship
+ Experience with complex business environments preferred
+ Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards
+ Experience in medical writing preferred
+ Integrity driven decision making skills
+ Collaboration and teaming with ability to work in a matrix environment
+ Strategic thinking & sound analytical skills
+ Big picture orientation with attention to detail
+ Sense of urgency & desire to excel
+ Intellectual curiosity
+ Self-awareness and adaptability
+ Result oriented and performance drive
+ Excellent interpersonal & communication skills to effectively interact with a broad range of audience
NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications
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.
This advertiser has chosen not to accept applicants from your region.

Regional Medical Advisor (RMA)

Sun Pharmaceuticals, Inc

Posted 2 days ago

Job Viewed

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Job Description

**YOUR TASKS AND RESPONSIBILITIES:**
+ Primary scientific face of the organization to Key Opinion Leaders (KOLs) & physicians for a given therapy area
+ Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis
+ Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan
+ Responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects
+ A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart
+ Jointly responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals
+ Representing the organization in various internal & external scientific platforms
+ Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams
+ Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan
+ Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction
+ Receiving and processing scientific information requests received from physicians
+ Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines
+ Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field
+ Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute
**WHO YOU ARE:**
+ Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity
+ Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data
+ Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship
+ Experience with complex business environments preferred
+ Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards
+ Experience in medical writing preferred
+ Integrity driven decision making skills
+ Collaboration and teaming with ability to work in a matrix environment
+ Strategic thinking & sound analytical skills
+ Big picture orientation with attention to detail
+ Sense of urgency & desire to excel
+ Intellectual curiosity
+ Self-awareness and adaptability
+ Result oriented and performance drive
+ Excellent interpersonal & communication skills to effectively interact with a broad range of audience
NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications
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.
This advertiser has chosen not to accept applicants from your region.
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Regional Medical Advisor (RMA)

Sun Pharmaceuticals, Inc

Posted 2 days ago

Job Viewed

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Job Description

**YOUR TASKS AND RESPONSIBILITIES:**
+ Primary scientific face of the organization to Key Opinion Leaders (KOLs) & physicians for a given therapy area
+ Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis
+ Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan
+ Responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects
+ A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart
+ Jointly responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals
+ Representing the organization in various internal & external scientific platforms
+ Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams
+ Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan
+ Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction
+ Receiving and processing scientific information requests received from physicians
+ Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines
+ Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field
+ Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute
**WHO YOU ARE:**
+ Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity
+ Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data
+ Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship
+ Experience with complex business environments preferred
+ Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards
+ Experience in medical writing preferred
+ Integrity driven decision making skills
+ Collaboration and teaming with ability to work in a matrix environment
+ Strategic thinking & sound analytical skills
+ Big picture orientation with attention to detail
+ Sense of urgency & desire to excel
+ Intellectual curiosity
+ Self-awareness and adaptability
+ Result oriented and performance drive
+ Excellent interpersonal & communication skills to effectively interact with a broad range of audience
NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications
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.
This advertiser has chosen not to accept applicants from your region.

Regional Medical Advisor (RMA)

Sun Pharmaceuticals, Inc

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**YOUR TASKS AND RESPONSIBILITIES:**
+ Primary scientific face of the organization to Key Opinion Leaders (KOLs) & physicians for a given therapy area
+ Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis
+ Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan
+ Responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects
+ A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart
+ Jointly responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals
+ Representing the organization in various internal & external scientific platforms
+ Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams
+ Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan
+ Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction
+ Receiving and processing scientific information requests received from physicians
+ Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines
+ Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field
+ Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute
**WHO YOU ARE:**
+ Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity
+ Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data
+ Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship
+ Experience with complex business environments preferred
+ Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards
+ Experience in medical writing preferred
+ Integrity driven decision making skills
+ Collaboration and teaming with ability to work in a matrix environment
+ Strategic thinking & sound analytical skills
+ Big picture orientation with attention to detail
+ Sense of urgency & desire to excel
+ Intellectual curiosity
+ Self-awareness and adaptability
+ Result oriented and performance drive
+ Excellent interpersonal & communication skills to effectively interact with a broad range of audience
NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications
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.
This advertiser has chosen not to accept applicants from your region.

Senior Medical Safety Advisor

Bangalore, Karnataka IQVIA

Posted 2 days ago

Job Viewed

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Job Description

Job Overview
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.
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
- Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
- Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable
- Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product's safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)
- Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective
- Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment.
- Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team
- Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives
- Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable
- Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable
- Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable
- Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable
- 24 hour medical support as required on assigned projects
- Maintain awareness of medical safety-regulatory industry developments
- Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable
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) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req
- Two (2) years of pharma experience Pref
- Sound knowledge of Medicine
- In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Knowledge of Pharmacovigilance- ICSR and Aggregate reports
- In-depth knowledge of departmental standard operating procedures (SOPs)
- Skill in use of multiple safety databases
- Adequate Computer skills, especially Microsoft word, excel & PowerPoint
- Good communication skills- verbal and written
- Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives
- 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
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  35. precision_manufacturing Industrial Engineering
  36. security Information Security
  37. handyman Installation & Maintenance
  38. policy Insurance
  39. code IT & Software
  40. gavel Legal
  41. sports_soccer Leisure & Sports
  42. inventory_2 Logistics & Warehousing
  43. supervisor_account Management
  44. supervisor_account Management Consultancy
  45. supervisor_account Manufacturing & Production
  46. campaign Marketing
  47. build Mechanical Engineering
  48. perm_media Media & PR
  49. local_hospital Medical
  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
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