Akums Drugs & Pharmaceuticals Ltd Hiring EXECUTIVE- PHARMACOVIGILANCE B.Pharm / M.Pharm Apply Now
Job Location:-
Haridwar (Uttrakhand)
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.
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