Benefit-Risk Excellence Lead (Sr PV Manager) - client-dedicated for 12 months

Work Schedule

Environmental Conditions

Job Description

Benefit-Risk Excellence Lead

The Benefit–Risk Excellence Lead will deliver short- and mid-term projects

that drive innovation and excellence within the Benefit–Risk Assessment &

Management (BRAMS) function. This includes enhancing procedures and

supporting digital transformation (automation and AI) This includes leading

transformational projects and supporting the implementation of project

outcomes (e.g., process/ SOP changes, etc.) within the signal detection and

safety writing systems.

The role requires significant experience in signal detection and safety writing

with strong industry and regulatory knowledge.

Key Responsibilities

• Governance, operating model, and portfolio prioritization support

• Executive stakeholder alignment and strategic decision support

• Transformation planning and roadmap development

• Initiative escalation and risk management

• Oversight across the portfolio

• Business case review

• Initiative mobilization support

• Business analysis and requirements gathering

• Support for Signal Detection and Benefit-Risk initiatives

• Process assessment and documentation

• Translation of business needs into system and process requirements

• Reporting, visualization, and documentation support

• Coordination between business stakeholders and technology teams

• Workshop planning and follow-up

• Day-to-day execution support

Required Skills & Experience

• 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.