Jubilant Pharmova Limited · Noida, Uttar Pradesh, India
About the job
Job Context: Manages global PV processes and activities including the surveillance of adverse events from all sources, clinical trials, post-marketing and literature, and the preparation of safety annual reports. Assists with management of safety database function, international PV agreements and safety data exchange processes with JDI’s affiliates, service providers and international business partners. Acts as the primary point of contact with healthcare professionals, customers and affiliates during investigation of case reports. Provides after-hour coverage of PV responsibilities as required and ensures compliance with drug safety regulations and ICH Guidelines.
Experience Range. MBBSwith relevant experience in the pharmaceutical industry required. Minimum of 10+ years in Pharmacovigilance in Pharmaceutical industry specifically focused on US FDA, Canada, Health Canada, EU and Non EU , Australia
- Ensures the collection, assessment, and review of adverse events (AEs) from all sources (clinical, spontaneous and literature) and expedited reporting to Regulatory Agencies (domestic and foreign).
- Reviews work conducted by the Pharmacovigilance specialist to ensures accuracy, quality and compliance of information.
- Understands the medical terminology, summarizes medical information, performs medical and medicinal data coding with MedDRA and WHO dictionaries, and keeps EudraVigilance database (XEVMPD) products information updated.
- Management of databases (i.e. safety drug data of all sources, literature review searches and scientific library for each product).
- Provides technical input in the development, review and evaluation of PV documentation/processes to ensure overall quality and compliance of work.
- Prepares and reviews Safety aggregated Reports (DSUR, ADSR, PADER, PSUR) in compliance with required timelines for submission.
- Remains current of PV regulations (Canada, US, Europe and International) to ensure compliance.
- Takes the lead and assists in the preparation of PV Agreements with national and international business partners. Negotiates agreements/contracts with external partners involved in drug safety reporting.
- Performs Safety Signal Detection activities and report any potential safety signal and concerns in a timely manner to the QHPV.
- Works with other functional areas to resolve issues related to the coordination and compilation of safety information for audits and quality review.
- Responsible for training, developing and managing performance of staff regarding their AE reporting obligation.
- Responds in a timely manner to requests/queries from clients, and business partners (including internal and external to JDI).
- Participates and/or paly as lead during internal and external PV audits.
- Liaises with internal and external JDI’s affiliates, national and international business partners to ensure compliance with the safety data exchange process.
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