RESPONSIBILITIES

- Support the execution of Pharmacovigilance (PV) related activities at Unichem Laboratories Limited
- Review literature articles with respect to validity
- Perform literature screening and maintain records of literature searches
- Perform triage and booking in Argus Database
- Complete data entry in Argus Database on a need basis
- Conduct quality review in Argus Database
- Perform Eudravigilance ICSR screening
- Prepare, review, and submit aggregate reports (Periodic Adverse Drug Experience Reports PADERs) as requested by regulatory authorities
- Prepare and maintain PV documents, SOPs (Standard Operating Procedures), and WIs (Work Instructions)
- Train PV team and relevant stakeholders on SOPs and WIs
- Manage global submissions




- Provide oversight on all activities related to case processing
- Organize training for corporate office, manufacturing plants, and other vendors for new and existing employees
- Provide satisfactory responses to all PV-related queries
- Manage reconciliation activities between Unichem and QPPV, business partners, distributors, and marketing authorization holders
- Carry out other responsibilities assigned by Head PVD / Supervisor / Designee

DESIRED SKILLS

- Good knowledge about GVP (Good Pharmacovigilance Practices) modules and guidelines
- Basic knowledge of Computers
- Valuable Communication skills

📌 Officer- Pharmacovigilance- Quality & Literature Review (Mumbai)
🏢 Unichem Laboratories
📍 Mumbai