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58 Biomedical Engineering Jobs in Bangalore / Bengaluru

PV Scientist, Senior Expert

4-9 years

Bangalore / Bengaluru

1 vacancy

PV Scientist, Senior Expert

Merck

posted 7d ago

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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What people at Merck are saying

Senior Expert salary at Merck

reported by 3 employees with 12-13 years exp.
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₹25 L/yr - ₹37.5 L/yr
78% more than the average Senior Expert Salary in India
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