PV Aggregate Reports Scientist
About The Position
The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and manages processes for aggregate reports, including PSURs, DSURs, PADERs, and local reports. The role serves as a subject matter expert on worldwide aggregate reporting safety requirements, providing guidance to the PV Scientist team and cross-functional partners. It responds to internal and external safety inquiries, reviews and supports authoring medical and scientific safety information, and works with vendors, vendor oversight, and Quality Management to maintain high-quality standards. The role also supports process improvements with PV Sciences and other cross-functional teams to develop and maintain compliant, efficient, and consistent practices across assigned product groups. The position leads and conducts aggregate safety report authoring and project management, supports the Aggregate Reports Master Schedule, reviews worldwide legislation and assesses its impact, and helps prepare responses to regulatory safety questions. It contributes to process improvements and signal-management consistency, supports process implementation and maintenance, and interprets, analyzes, and presents scientific and medical data. The role collaborates across Safety, Clinical Development, and other functions and applies clinical judgment to interpret case information and guide staff.
Requirements
- Bachelor’s degree in a biologic or natural science.
- Minimum 5 years of pharmacovigilance experience, including aggregate safety report writing and safety signal management.
- Familiarity with pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations.
- Strong organizational skills and ability to prioritize independently.
- Basic knowledge of common data-processing software, including Excel, PowerPoint, Microsoft Word, and Business Objects.
- Knowledge of common safety database systems.
Nice To Haves
- Advanced degree (MSc, PhD, MPH, PharmD, etc.).
- Advanced understanding of medical concepts and terminology.
- Demonstrated authoring experience within pharmacovigilance.
- Strong collaborative skills within cross-functional teams.
Responsibilities
- Lead and conduct aggregate safety report authoring and project management, independently and collaboratively.
- Serve as a subject matter expert on safety requirements and pharmacovigilance activities, representing processes in cross-functional forums.
- Support production, updates, and stakeholder reviews for the Aggregate Reports Master Schedule.
- Review worldwide legislation related to aggregate reports and provide impact assessments.
- Assist in authoring responses to regulatory authority safety questions in collaboration with stakeholders.
- Contribute to process improvement and consistency in aggregate reports and signal management.
- Support implementation and maintenance of new and existing processes.
- Interpret, analyze, and present scientific and medical data in verbal and written formats.
- Collaborate with team members and external colleagues across Safety, Clinical Development, and other functions.
- Apply clinical judgment to interpret case information and guide staff in interpretation.
- Respond to internal and external safety inquiries and support review and authoring of medical and scientific safety information.
- Work with vendors, vendor oversight, and Quality Management to ensure high-quality standards.
Benefits
- Medical, dental, vision, and life insurance.
- Fitness and wellness programs, including fitness reimbursement.
- Short- and long-term disability insurance.
- Minimum of 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31.
- Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
- 80 hours of sick time per calendar year.
- Paid maternity and parental leave.
- 401(k) program with company-matched contributions.
- Employee stock purchase plan.
- Tuition reimbursement of up to $10,000 per calendar year.
- Employee Resource Groups participation.
- Eligible for short-term and long-term incentives, including cash bonus and equity incentive opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
