We are seeking a highly motivated Incumbent with experience in Medical Affairs, Pharmacovigilance and Clinical Research to join our dynamic team.

ROLE OVERVIEW:

- The candidate will be a pivotal figure in our commitment to upholding the highest medical, clinical research and Pharmacovigilance standards. His/her primary responsibilities will include:

Medical Affairs

1. Monitoring and evaluating the safety profile of the clinical study, including adverse event reporting and risk management activities.

2. Overseeing and supporting clinical research activities, including designing, and conducting clinical trials, analysing data, and interpreting results.

3. Providing medical and scientific input for regulatory submissions, including clinical study reports, Investigator's Brochures, and responses to regulatory agencies' inquiries.

4. Generating scientific content such as manuscripts, abstracts, posters, research papers and presentations based on clinical trial data.

5. Contribute to protocol development, investigator meetings, and data analysis, as well as interpreting study results and implications.

5. Building and maintaining relationships with key leaders in relevant therapeutic areas. This involves providing them with scientific information, seeking their input on clinical development programs.

6. Responding to medical inquiries from regulatory authorities, Investigators, sponsor, other stakeholders. Ensuring that accurate and up-to-date medical information is provided in a timely manner.

PVG Activities

1. Establish and maintain a Pharmacovigilance system that collects, evaluates, and reports adverse events and safetyc data.

2. Ensures that the marketing authorization holder (MAH) complies with pharmacovigilance regulations and guidelines.

3. Monitoring product safety, emerging safety concerns, and risk-benefit balance of the MAH products and review safety signals, including any open signals that require further investigation.

4. Timely submission of periodic safety update reports (PSURs) and other required safety reports to regulatory authorities.

5. Oversee the exchange of safety data through Safety Data Exchange Agreements (SDEAs) with partners and stakeholders.

6. Interacts with key stakeholders and contacts, such as healthcare professionals, patients, regulatory bodies, and vendors/partners.

7. Oversee Pharmacovigilance System Master File (PSMF), which provides an overview of the pharmacovigilance system and Oversight over the functioning of the PV system in all aspects, including the quality system.

8. Round-the-clock (24/7) availability as the single PV point of contact.

9. Performing medical evaluation of clinical trial serious adverse events (SAEs), Adverse Events of Special Interest (AESI) along with serious & non-serious adverse events from various post-marketing sources.

10. Ensure accurate and consistent medical coding through MedDRA (Medical Dictionary for Regulatory Activities) for all events in database.

11. Data verification between source documents and entered data in database for evaluation of events/suspect drug coding, seriousness, causality, listed ness and narrative writing.

12. Triage and Quality check of literature cases, checking for the possible company suspects by evaluating the literature abstracts.

13. Ensure that quality of case processing and assigned tasks are evaluated and trends are identified for process improvement.

14. Various compliance metrics like case timelines, assigned trainings, and TAT for assigned activities are met.

15. Provide analytical support to the peers and managers for investigations & analysis of various trends as a part of project and providing PV or product-specific training.

16. Other task assigned by the HOD / Management.

Qualifications:

- To excel in this role, you should possess MBBS degree or MD degree

Experience :

- 2-3 years of experience in Medical Affairs, Clinical Research activities and Pharmacovigilance, with a comprehensive understanding of safety reporting, document management, and regulatory guidelines.

- Proven leadership skills, with the ability to guide and motivate a team toward achieving goals and maintaining high-quality standards.

- Strong familiarity with sponsor specifications, SOPs, and pharmacovigilance guidelines to ensure meticulous execution of tasks.

- Excellent communication and collaboration skills to work effectively across departments and uphold compliance with company policies.

Location: Delhi NCR

Job Type: Full-Time