Akums Drugs & Pharmaceuticals Limited – Urgently Openings for Pharmacovigilance || Apply Online Vacancy Details:-
Post – Manager- Corporate Pharmacovigilance
Qualification – B. Pharma, M. Pharma
Req. Experienced – 8 – 12 yr
Location – Haridwar (Uttrakhand)
To perform all activities of Pharmacovigilance related functions and ensure that all tasks are performed according to business rules, regulatory guidelines and standard operating procedures.
Responsible for conducting overall Global Pharmacovigilance activities and maintenance of Pharmacovigilance (PV) Safety Database.
Responsible for preparation and maintenance of Pharmacovigilance System Master File (PSMF).
Responsible for preparation, review and implementation of Standard Operating Procedures/ Work Instructions.
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 PSUR (Periodic Safety Update Report) development and submission to 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 medicinal products
Responsible for effective compliance of all PV systems.
Responsible for coordinating with different Marketing Authorization Holders (MAHs)/ clients/Regulatory Authorities on a 24-hour basis related to Pharmacovigilance activities & queries.
To provide the expert comments in process of reference safety information updates.
Responsible for Post Marketing Surveillance Studies / Non interventional Observational Cohort Studies etc.
To host and facilitate the internal and external audits/ inspections.
To impart pharmacovigilance training to team members and other departments related to PV procedures and regulatory obligations.
To evaluate potential medically relevant pharmaceutical product complaints