Greetings from Akums Drugs & Pharmaceuticals Ltd..!!
We are hiring following positions for Haridwar (Uttarakhand) Location
Qualification: B.Pharmacy/ M.Pharmacy (Pharmacy)
Experience: 3 – 5 years
Location: Haridwar (Uttarakhand)
- 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 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 preparation and maintenance of Pharmacovigilance System Master File (PSMF).
- Responsible for global and local literature surveillance.
- Responsible for ICSR management and submission to applicable regulatory authority.
- Responsible for development and maintenance of PV Safety Data Exchange Agreement (SDEA) of different clients.
- To review and approve 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 applicable regulatory authority.
- Responsible for Signal detection and continuous monitoring of 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/ non interventional 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.