Manager

Mankind Pharma has emerged as one of the fastest growing companies in the Indian Pharmaceutical Market (with a focus on quality and affordability. Our success stems from a robust portfolio that has played an integral role in outpacing IMP growth. It has also resulted in volume led growth f or Mankind. We aspire to deliver integrated solutions to our valued customers with a strong focus on research and development innovation, and customer centricity.

Manager - Drug Safety Physician

Join Our Journey of Excellence in Pharmacovigilance!

At Mankind Pharma Ltd., we are committed to improving lives by delivering high-quality healthcare solutions. As a rapidly growing organization, we are seeking a passionate and experienced professional to join our team as Manager- Pharmacovigilance Drug Safety Physician at our Head Office in Okhla, Delhi.-

Department Pharmacovigilance
Qualification MBBS (Bachelor of Medicine, Bachelor of Surgery) and/or MD (Doctor of Medicine).
Years of Experience 10-12 years of hands-on experience in a comparable role, demonstrating similar responsibilities and expertise
The Drug Safety Physician should be demonstrated experience in key pharmacovigilance deliveries such as Individual Case Safety Reports (ICSRs), Aggregate Reports and Signal Detection activities.

Key Responsibilities:

• Medical review of individual case safety reports (from all sources), seriousness, Labeling/expectedness, and company causality assessments as well as writing company comments, follow up queries and AOSE analysis as needed.
• To provide medical support the Qualified Person for Pharmacovigilance as needed.
• To review literature screening search strategy.
• Supporting writing and medical review of all aggregate reports including: PSUR, PBRER, PADER, Annual Reports, DSURs, ACOs for ensuring and assessing benefit Risk assessment.
• Provide medical support for signal detection ensuring signal detection is conducted in a regular, timely manner in accordance with schedule. Communicate outcome of SD to senior management.
• Conduct aggregate safety data review on an ad hoc basis to support benefit-risk evaluations
• Prepare and/or review Health Hazard Assessment Reports and other ad hoc safety reports as requested
• Provide medical input to other cross-functional documents such as study protocol and other documents. Provide product training pertaining to safety profile to relevant stakeholders.
• Provide medical support to commercial, marketing and Medical Affairs teams relevant for Pharmacovigilance activities as required
• Perform review of safety sections of Reference safety Information documents such as, Investigator Brochures (IB), Product Inserts (PIs), US PI and patient information leaflets (PILs) to ensure the most up to date and accurate safety information is present in all labeling information
• Act as SME for above activities during audit and regulatory authority inspections, as needed.
• Relationship Management
• Working within PV team and cross-functionally with key stakeholder functions including Clinical, Regulatory Affairs, Medical Affairs, Commercial Teams and Business Units
• Interactions with vendors /service providers for medical activities

Additional Remarks
Collaboration: Collaborating with cross-functional teams to ensure compliance with safety regulations.
Communication: Outstanding presentation, interpersonal, verbal, and written communication skills.
Time Management: Excellent time management skills.
Technical Skills: Experience with leading computer applications (like ARGUS, ARISg) including database management and Pharmacovigilance related computing systems.