PV Scientist, Senior Expert

Job Description

Title: PV Scientist - Senior ExpertLocation: Bangalore Purpose of the Role: We are seeking a highly motivated and skilled Pharmacovigilance Scientist to collaborate with global safety leads and program safety leads This role is essential for providing integrated medical safety strategies for assigned investigational and core (high-risk) marketed products, including input into safety aspects of clinical development, risk management, and benefit-risk management Your roleSignal Detection and Management:Perform safety monitoring using dedicated tools (eg, Spotfire, EVDAS, Empirica Signals) for signal detection Review and analyze clinical and safety database outputs; interpret aggregate safety data from clinical trials and post-marketing sources Review scientific literature for safety surveillance and signal detection Support the analyses of safety signals, contribute to authoring signal evaluation reports, and participate in relevant safety governance meetings Support communication of findings from Emerging Safety Issue Reports to external stakeholders RMP Updates and Periodic Safety Reports:Retrieve/summarize data from various sources in support of authoring and providing content for Risk Management Plans (RMPs) and periodic safety reports Support local adaptation of RMPs and respond to health authority questions Submissions and Safety Variations:Contribute to delivery of safety relevant documents of the Common Technical Document (CTD) Contribute to ISS/SCS IAP, health authority briefing documents, and product information and clinical overview addendum Clinical Trial Activities: Provide input into safety sections of the Investigational Medicinal Product Dossier (IMPD), Investigators Brochure (IB), and Informed Consent Form (ICF) Support delivery of safety-related input for clinical trial documents, including protocols and reports Provide safety related input for data monitoring committees with safety-related documentation Other Activities:Respond to queries from auditors/inspectors and participate in interviews Contribute to the design and implementation of post-authorization safety studies Develop and maintain MedDRA CMQs for signal analysis and aggregate safety data Create product-specific training for internal and external stakeholders Provide expert input into process standardization and improvement within GPS and GD Who you are: Experience Required:MD, or PhD/advanced science degree or tertiary level qualifications in a biomedical/health related field Fluent in written and spoken English Qualification:Over 4 years of Pharmaceutical industry experience or similar (egHealth Authority) Experience in Pharmacovigilance risk management in both clinical development and post-marketing areas, including submission experience Ability to work collaboratively in a global team environmentTech savy with strong analytical and communication skills