Cadila Pharmaceuticals is inviting applications for the position of Medical Reviewer and Pharmacovigilance Officer in Charge (PVOIC) at its Ahmedabad location. This is an excellent opportunity for candidates with expertise in pharmacovigilance, medical review of Individual Case Safety Reports (ICSRs), aggregate safety reports, and drug safety regulations.
Professionals looking for Medical Reviewer jobs in Ahmedabad, pharmacovigilance jobs in India, and drug safety career opportunities at Cadila Pharmaceuticals can explore this full-time permanent position in the pharmaceutical and life sciences sector.
Job Details
- Position: Medical Reviewer and PVOIC
- Company: Cadila Pharmaceuticals
- Location: Ahmedabad, Gujarat, India
- Department: Research & Development
- Employment Type: Full Time, Permanent
- Industry: Pharmaceutical & Life Sciences
- Experience: Not Specified
- Number of Openings: 1
- Education: BDS (Bachelor of Dental Surgery)
Key Responsibilities
The selected candidate will be responsible for:
- Performing medical review of Individual Case Safety Reports (ICSRs) from clinical trials, post-marketing surveillance, literature, and other sources.
- Reviewing pharmacovigilance documents, including:
- Periodic Safety Update Reports (PSUR)
- Periodic Adverse Drug Experience Reports (PADER)
- Risk Management Plans (RMPs)
- Risk Evaluation and Mitigation Strategies (REMS)
- Addendum to Clinical Overview (ACO)
- Signal reports
- Reviewing Summary of Product Characteristics (SmPC), Package Inserts (PI), and Patient Information Leaflets (PIL).
- Conducting causality assessments and providing medical judgment for safety cases.
- Maintaining signal detection trackers and supporting signal management activities.
- Assisting with regulatory queries and Requests for Information (RFIs).
- Supporting internal audits and external pharmacovigilance inspections.
- Training new team members on medical review processes.
- Developing training modules and organizing pharmacovigilance training programs.
- Identifying pharmacovigilance activities and drafting or revising Standard Operating Procedures (SOPs).
- Acting as the single point of contact for competent authorities on a 24-hour basis as PVOIC.
Required Skills
Candidates with the following skills will be preferred:
- Medical review of ICSRs
- Pharmacovigilance operations
- Aggregate safety reporting
- Signal detection and management
- Regulatory compliance and inspections
- Risk management planning
- Causality assessment
- SOP development and revision
- Safety variation activities
- Training and mentoring capabilities
Educational Qualification
- Bachelor of Dental Surgery (BDS) in any specialization.
- Additional exposure to pharmacovigilance and drug safety processes will be advantageous.
Why Join Cadila Pharmaceuticals?
Joining Cadila Pharmaceuticals offers opportunities to:
- Work in a well-established pharmaceutical organization.
- Gain experience in global pharmacovigilance practices.
- Contribute to drug safety and regulatory compliance initiatives.
- Develop expertise in medical review and aggregate safety reporting.
- Participate in regulatory inspections and quality improvement programs.
- Build a long-term career in pharmacovigilance and drug safety.
How to Apply
