Unichem Laboratories Limited Pharmacovigilance Job Opening – Apply Online
Officer / Senior Officer – Pharmacovigilance
Mumbai, Maharashtra, India
About the job
Qualification: B.Sc / M.Sc / B. Pharm / M.Pharm
Experience: 1 to 5 Years
Job Responsibilities
- Support the execution of Pharmacovigilance (PV) related activities at Unichem Laboratories Limited.
- Preparation and maintenance of PV documents, SOPs (standard operating procedures) and WI (work instruction).
- To train the PV team and relevant stakeholders on SOPs and WIs.
- Organizing training for the corporate office, manufacturing plants, and other vendors if applicable, in a timely manner for new as well as existing Unichem Laboratories employees.
- Assist the PV team to execute all PV-related activities.
- Preparation and review of Aggregate reports (PADERs, PSURs, PBRERs) and RMPs (Risk Management Plan) or any other document as requested by regulatory authorities.
- Submission of Aggregate Reports and RMPs to regulatory authorities.
- To ensure PV compliance in accordance with Unichem Lab SOPs and regulatory requirements.
- Coordination with PV service providers for day-to-day PV activities.
- To support in the selection, audit, oversight, and conduct of regular meetings with service providers for PV activities.
- To provide satisfactory responses to all PV-related queries.
- To support the Medical Affairs team to respond to inquiries from PV sources.
Desired skills
- Fluent in medical terminology
- Ability to coordinate with internal and external stakeholders
- Strong analytical, communication, and presentation skills
- Proactive approach
Apply for this position at: Original Notification
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