Benefit-Risk Excellence Lead, Sr PV Manager

🔥 6 minutes ago

🇷🇸 Serbia – Remote

⏰ Full Time

🟠 Senior

🎲 Risk

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Deliver short- and mid-term projects driving innovation and excellence within the Benefit–Risk Assessment & Management function • Enhance procedures and support digital transformation, including automation and AI • Lead transformational projects and support implementation of project outcomes, such as process and SOP changes, within signal detection and safety writing systems • Support governance, operating model, and portfolio prioritization • Align executive stakeholders and provide strategic decision support • Develop transformation plans and roadmaps • Escalate initiatives and manage risks • Provide oversight across the portfolio • Review business cases • Support initiative mobilization • Conduct business analysis and requirements gathering • Support Signal Detection and Benefit-Risk initiatives • Assess and document processes • Translate business needs into system and process requirements • Support reporting, visualization, and documentation • Coordinate between business stakeholders and technology teams • Plan workshops and follow up • Provide day-to-day execution support

🎯 Requirements

• Relevant Life-Sciences Bachelors Degree • >10 years of biopharmaceutical industry experience, with significant hands-on expertise in signal detection, safety writing, and risk management across the full drug development lifecycle. • Strong knowledge of global GCP and GVP regulations, industry standards, and evolving regulatory expectations. • Proven change-leadership experience, including identifying needs, designing and implementing creative solutions, leading teams through transitions, and monitoring outcomes to ensure value delivery. • Demonstrated adaptability and resilience, maintaining progress and stability in dynamic or challenging environments. • Excellent communication skills, including clear and articulate verbal, written, and presentation abilities, with strong command of English language. • Ability to work independently, manage multiple priorities, and collaborate effectively in a matrixed organisation.

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