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119 Merck Jobs
PV Scientist, Senior Expert
Merck
posted 7d ago
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Flexible timing
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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
Employment Type: Full Time, Permanent
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Senior Specialist - Regulatory Submission Management
6-8 Yrs
Bangalore / Bengaluru
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