Akums Drugs & Pharmaceuticals Limited Released Job Openings On 04-05-2022.Akums Drugs & Pharmaceuticals Ltd., is largest contract manufacturing company engaged in manufacturing of pharmaceutical formulation, ayurvedic/herbal preparations, hormones, nutraceuticals and more.
Vacancy Details:
Akums Drugs & Pharmaceuticals Limited Recruiting B.Pharma,M.Pharma with 10-12 years of Experience for Manager/ Sr. Manager- Pharmacovigilance Position.Complete Details for the Manager/ Sr. Manager- Pharmacovigilance as follows.
Important Details :
- Location :Haridwar
- No of Vacancies:NA
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 04-05-2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Related Job : Work From Home / Office : Parexel Virtual Recruitment drive on 10th May 2022
Job Description/Skills Required
- 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.
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