Aggregate Reports PV Scientist | Zug, CH
Vor 7 Tagen
Job description:
On behalf of our client, a leading biopharmaceutical company, we are seeking an Aggregate Reports PV Scientist to join the Safety Surveillance and Aggregate Reports team.
Requirements:
Aggregate Safety Reporting & Compliance:
- Project management and authoring of aggregate safety reports (PSURs, DSURs, PADERs, and local reports) in collaboration with the PV Scientist Lead.
- Ensure compliance with global pharmacovigilance (PV) 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 (production, updates, stakeholder review).
- 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.
Competences:
Education:
- Bachelor's degree in biological or natural sciences.
- Advanced degree (MSc, PhD, MPH, PharmD) is preferred.
Experience:
- 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.
Skills:
- 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.
Compensation benefits:
- 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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