Unichem Laboratories Limited
Location
Mumbai | India
Job description
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 to corporate office, manufacturing plants and other vendors if applicable, in 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. Co-ordination with PV service providers for day-to-day PV activities. To support in the selection, audit, oversight and conduct regular meetings with service providers for PV activities. To provide the satisfactory response to all PV related queries. To support the Medical Affairs team to respond to enquiries from PV sources. Desired skills Fluent in medical terminology Ability to coordinate with internal and external stakeholders Strong Analytical, communication and presentation skills Proactive approachJob tags
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