Pharmacovigilance Specialist Job Responsibilities
- Contributes to production of high quality of aggregate report, Safety Review meeting coordination, signal detection activities, and clinical development and product registrational activities.
- Oversees and assumes responsibility for assigned therapeutic products and PV activities through the lifecycle of the product.
- Supports an organizational structure that meets the evolving needs of Shire and the GDS department.
- Fosters a collaborative culture within the product team and to external stakeholders.
- Responsible for the production of periodic and ad-hoc safety reporting for therapeutic team products, where the client is the Global Safety Database holder.
- Creates, coordinates, prepares and completes aggregate reports (e.g. PBRER, DSUR, PADER, as well as ad hoc queries or reports) for submission to regulatory agencies around the world.
- Collaborates with the Global Safety Lead to ensure that all information is available to allow for informed medical review and benefit-risk assessment.
- Responsible for the quality of the final document and uses the client's EDMS system to provide quality control.
- Provides the technical and scientific support for safety surveillance and signal detection activities for assigned client products via established signal detection methodology and tools.
- Evaluate signals promptly in signal detection reports and ad-hoc responses to regulatory authorities.
- Responsible for efficiently planning Safety Review Team (SRT) meetings, ensuring that stakeholders provide input from their respective areas of responsibility.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.