PV Scientist with Expertise in Aggregate Reporting

Vor 3 Tagen


Luzern, Luzern, Schweiz Swisslinx Vollzeit
Aggregated Safety Reports PV Specialist

About the Role:

We are seeking an experienced Aggregate Reports PV Scientist to join our team at Swisslinx. As a key member of the Safety Surveillance and Aggregate Reports team, you will be responsible for project management and authoring of aggregate safety reports.

Main Responsibilities:

  • Aggregate Safety Reporting & Compliance: Ensure compliance with global pharmacovigilance regulations and company safety policies. Serve as a subject matter expert on aggregate reporting safety requirements worldwide.

  • Regulatory & Process Improvement: Manage the Aggregate Reports Master Schedule and worldwide legislation overview. Coordinate and author responses to regulatory authorities' safety questions. Contribute to process improvement initiatives to enhance consistency in aggregate reporting, clinical trial safety oversight, and signal management.

  • Collaboration & Oversight: Work closely with vendors, vendor oversight teams, and the Quality Management team to ensure high-quality PV documentation. Represent and speak to PV processes in cross-functional forums, collaborating with teams in Safety, Clinical Development, Medical Affairs, and Regulatory Affairs.

Requirements:

  • Bachelor's degree in biological or natural sciences; Advanced degree preferred.

  • 8-10 years of pharmacovigilance experience, including experience in aggregate safety report writing and safety signal management.

  • At least 2 years of experience managing direct reports.

  • Strong understanding of pharmacovigilance and drug development, including clinical trial safety regulations and post-marketing safety regulations.

  • Ability to interpret and analyze medical and scientific data.

  • Strong organizational and project management skills with minimal supervision.

  • Familiarity with safety databases and software such as Excel, PowerPoint, and Business Objects.

  • Excellent communication skills and ability to work in a cross-functional team.

What We Offer:

  • An exciting opportunity to work with a leading biopharmaceutical company in pharmacovigilance.

  • A collaborative and dynamic work environment with opportunities for professional growth.



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