Job description
Please find the JD below
• Preparation of PADERs / PSURs / PBRERs and DSURs as per SOP and co-ordinate with cross functional teams including vendors for the completion of reports on time and with quality.• Preparation and updating Safety review schedule as per the Pharmacovigilance regulations and standard operating procedure on timely basis. Support the medical lead in the analysis and preparing of signals and signal evaluation reports for all products for all entities. Co-ordinate with the lead medic in organising and conducting the safety review meetings. Monitor different regulatory authority websites for new signals.
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• Generate line listings from the safety database as per the review period and incorporate the data in the signal report.• Training on PV system to be provided to Vendors, new joiners and cross functional teams.• Monitor the relevant trackers and logs within PV system for the regular updates.• Co-ordinate with Vendors, internal team and relevant stake holders for maintaining and updating on relevant activity.• Preparation of Safety Data Exchange Agreements (SDEAs)/ Pharmacovigilance agreements (PVAs).• Preparation of the Standard Operation Procedures (SOPs) and/ or WIs through Track Wise or manual process as per the standards.
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• Label update on company website and portal / SharePoint.• Perform literature search for the products post Data Lock Point (DLP) and review of the literature hits for safety information.
Role: Clinical research ScientistIndustry Type: Pharmaceutical & Life SciencesDepartment: Research & DevelopmentEmployment Type: Full Time, PermanentRole Category: Pharmaceutical & BiotechnologyEducationPG: M.Pharma in Any Specialization
