Unichem Laboratories Released Job Openings On 14/05/2022.Promoted by the late Mr. Amrut Mody, a pioneer of the Indian pharmaceuticals business, Unichem Laboratories has grown to become one of India’s most respected pharmaceutical companies. It is committed to deliver better health through superior products.
Unichem Laboratories Recruiting B.Pharma, M.Pharm Candidates with 10 – 12 years of Experience for Manager- Medical Affairs and Pharmacovigilance Position.Complete Details for the Manager- Medical Affairs and Pharmacovigilance as follows.
Important Details :
- Location :Mumbai
- No of Vacancies:01
- Details of Salary: NA
- Opening date for online Application: 14/05/2022
- 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
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Job Description/Skills Required
- Support and execute Pharmacovigilance related activities in UNICHEM Laboratories Limited.
- Prepare and maintain Pharmacovigilance documentation and SOPs and train relevant stake holders.
- Train PV team on standard operating procedure (SOP) and work instruction.
- Train PV team for conducting PV training and related programs.
- Organize PV training to corporate office, manufacturing plants, distributors, and other vendors if applicable in timely manner for new as well as existing UNICEM employees.
- Assist the Pharmacovigilance team to execute all PV related activities.
- Prepare the periodic safety update reports (PSURs) and submit to the regulatory authorities. and risk management plans (RMPs) contribute to Pharmacovigilance matrix to ensure that the PV system is running in compliance with procedure and requirements.
- Co-ordinate with business partners for preparation and update of SDEA agreements. Prepare and review PV related documents such as PSURs, PBRER, RMPs, PADER, SmPC, package insert and submission to regulatory agencies.
- Provide the satisfactory response to all medical information and PV related queries.
- Communicate with vendors in case of discrepancies.
- Train QPPV on SOPs and pharmacovigilance.
- Submit individual case safety reports to regulatory authorities.
- Support the Medical Affairs team to respond enquiries from Pharmacovigilance source.
- Timely submission of PADERs and process invoices in SAP system for payment release.
- Support in the selection, audit, oversight and conduct regular meetings with service providers (vendors and CROs) for PV activities.
- Ensure that all PV activities are conducted in accordance with UNICHEM SOPs and regulatory requirements.