Akums Drugs & Pharmaceuticals Ltd. is the largest contract manufacturing company engaged in the manufacturing of pharmaceutical formulation, ayurvedic/herbal preparations, hormones, nutraceuticals, and more. Quality, innovations & customer satisfaction are virtues at Akums. The approach is technologically driven to serve the emerging needs in the ever-expanding market. The 9 states of art facilities are dedicated to separate dosage forms across therapeutic segments. The infrastructure is equipped with sophisticated and ultra-modern equipment & machines, with huge manufacturing capacities in all sections. In our continuous pursuit of Healthier today and tomorrow, we are working towards redesigning global healthcare
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Designation: Pharmacovigilance Executive
Location: Haridwar, Uttrakhand, India
- Responsible for PSUR (Periodic Safety Update Report) development and submission to applicable regulatory authority.
- To assist in pharmacovigilance training to team members and other departments related to PV procedures and regulatory obligations.
- To assist the head of the department in preparation /revision of Standard Operating Procedures/Work Instructions.
- Responsible for conducting overall Pharmacovigilance activities and maintenance of Pharmacovigilance (PV) safety database.
- Responsible for the preparation and maintenance of the Pharmacovigilance System Master File (PSMF).
- Responsible for global and local literature surveillance.
- Responsible for ICSR management and submission to applicable regulatory authority.
- Responsible for the development and maintenance of the PV Safety Data Exchange Agreement (SDEA) of different clients.
- To review and approve the final ADR/AE assessment report and related activities.
- Responsible for handling and reporting of all SAEs to DCGI and other applicable regulatory authority.
- Responsible for RMP (Risk Management Plan) development and submission to an applicable regulatory authority.
- Responsible for Signal detection and continuous monitoring of the safety profile of all medical products.
- Responsible for coordinating with different Marketing Authorization Holders (MAHs)/ clients/ Regulatory Authorities on a 24-hour basis related to Pharmacovigilance activities & queries.
- Responsible for PMS (Post Marketing Surveillance) studies/noninterventional observational cohort studies etc.
- Will be involved in audit/inspection plans and Corrective Actions Preventative Actions (CAPAs).
- To evaluate potential medically relevant pharmaceutical product complaints.