Aggregate Reports PV Scientist

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.