Company Details

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.

Job Title

Manager- Pharmacovigilance Aggregate Analysis

Job Description

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 Aggregate Analysis at our Head Office in Okhla, Delhi.

Job Specification:
Department                 Pharmacovigilance
Qualification               M.Pharm or Postgraduate in Life Sciences is mandatory. MBBS qualification preferred but optional.
Years of Experience    8-10 years of hands-on experience in a comparable role, demonstrating similar responsibilities and expertise.

Skill Set Needed     
•    Proven expertise and hands-on experience in conducting benefit-risk assessments, including the preparation, review, and submission of various aggregate safety reports such as PSURs (Periodic Safety Update Reports), PBRERs (Periodic Benefit-Risk Evaluation Reports), DSURs (Development Safety Update Reports), and PADERs (Periodic Adverse Drug Experience Reports).
•    Ownership and management of the signal detection process, ensuring timely identification, evaluation, and documentation of potential safety signals.
•    Experience in preparing and updating Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), including identification, implementation, and monitoring of risk minimization measures.
•    Active contribution in drafting responses to regulatory authority queries related to aggregate reports and safety data.
•    Proficiency in preparing Health Hazard Evaluation Reports, providing risk assessments for potential safety concerns.
•    Expertise in reviewing Reference Safety Information (RSI) in collaboration with the Medical Team, ensuring alignment with evolving safety data and regulatoryexpectations.

Key Responsibilities
•    Owning end-to-end process of Aggregate Reports: scheduling, development and submissions of all kind of Aggregate Reports with good quality. 
•    Technical review of aggregate reports including PSUR, PBRER, PADER, Annual Reports, DSURs, ACOs. 
•    Preparation of aggregate reports including PSUR, PBRER, PADER, Annual Reports, DSURs as needed. 
•    Ensure all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements 
•    Maintaining RMPs Calendar and other safety related documents. Development or review of RMPs and contribute to REMS activities as required 
•    Overseeing Signal Detection activities for all Company products as required, ensuring signal detection are being conducted in a regular, timely manner in accordance with schedule. 
•    Oversight for risk minimization measures in collaboration with relevant cross functional teams.

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 Emperica, ARISg- LSSRM) including database management and Pharmacovigilance related computing systems

Competencies