Aggregate Report PV Scientist
Job Summary
This role is responsible for managing the processes for all aggregate reports, working closely with vendors and Quality Management team to ensure high quality standards of PV documents.
About the Role
This mid-senior level position requires a strong background in pharmacovigilance and drug development, including knowledge of clinical trial safety regulations and post-marketing safety regulations.
* Project management and authoring of aggregate safety reports such as PSURs, DSURs, PADERs, local reports.
* Serves as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as aggregate reports knowledge.
* Support with process improvement; implements and maintains processes.
* Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview (production, update, stakeholders review).
Your Profile
To be successful in this role, you will need:
* BSc degree in biologic or natural science advanced degree (MSc, PhD, MPH, PharmD, etc.)
* Minimum 8 years Pharmacovigilance experience, including experience in aggregate safety reports writing and safety signal management.
* Strong organizational skills, including the ability to prioritize independently with minimal supervision.
* Familiarity with common data processing software (Excel, PowerPoint, Microsoft Word, Business Objects) and common safety database systems.
Seniority Level
Mid-Senior level
Employment Type
Contract
Job Function
Quality Assurance, Project Management, and Science
Industries
Staffing and Recruiting