Merck KGaA

Lead PV Scientist

Posted On

Oct. 17, 2024

Location

Bangalore, Karnataka

Experience Level

E - Professional (10+ years)

Job Type

full-time

Apply By

Jan. 28, 2025

Job Description

Purpose of the Role: We are seeking a highly 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. Signal Detection and Management:Review reports and data in dedicated tools (e.g., Spotfire, EVDAS, Empirica Signals) for signal detection.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.Analyze safety signals, author signal evaluation reports, and contribute to relevant meetings.Contribute to developing Emerging Safety Issue Reports and communicate findings to external stakeholders.Benefit/Risk Activities:Defining safety profiles, identifying important risks and safety concerns.Contribute content to benefit-risk strategy documents.RMP Updates and Periodic Safety Reports:Author and provide 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:Provide strategic input into safety documents of the Common Technical Document (CTD).Contribute to ISS/SCS IAP, health authority briefing documents, and product information.Respond to health authority inquiries related to submissions and safety variations.Clinical Trial Activities:Provide input into safety sections of the Investigational Medicinal Product Dossier (IMPD), Investigator's Brochure (IB), and Informed Consent Form (ICF).Contribute safety-related input for clinical trial documents, including protocols and reports.Support 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: MD: Clinical experience and pharmaceutical industry experience or similar (e.g. Health Authority); PhD/advanced science degree:Over 10 years of Pharmaceutical industry experience or similar (e.g. Health Authority).Advanced experience in Pharmacovigilance in both clinical development and post-marketing areas, including submission experience.Ability to work collaboratively in a global team environmentStrong analytical and communication skills

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