DUTIES & RESPONSIBILITIES
• Manage daily workload in conjugation with line manager for individual case processing, literature searches, aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department.
• Medical Review of ICSR’s in pharmacovigilance database and aggregate reports for expedited/periodic submission as per the Regulations and SOPs.
• Signal detection of the ADRs with cases received from client’s products
• Medical Review of PSUR as per the Regulations and SOPs
• Handling of medical query/spontaneous ADR cases as per applicable SOP • Generation and review of SOPs and WIs and execution of company SOPs
• Maintain awareness of changes to/new regulations affecting PVG activities




• Compliance to project guidelines • Trains and mentors new employees in PVG (if required)
• To carry out necessary administrative duties required for the job
• Other duties as assigned by management • Builds and maintains good relationships across functional units and company affiliates

Requirements
REQUISITE EDUCATION LEVEL & EXPERIENCE
- A graduate/post-graduate degree in medical science.
- 0-2 yrs. relevant experience;
- Knowledge of regulatory requirements
- Good time management skills
- Positive presentation skills
- Ability to plan & prioritise projects and work effectively
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- Good communication skills

📌 Drug Safety Physician (Noida)
🏢 APCER Life Sciences India
📍 Noida