Principal Drug Safety Scientist

Participate in adverse event (AE) case management, related adverse event management activities, processing cases under the single case ownership models to remain current with the activity and providing support in the management of the case and its prioritization. Support the entire lifecycle of products by applying sound medical judgment for analysis and interpretation of safety data for signal detection and safety risk management activities, including safety specification, PV planning, and risk minimization/mitigation in support.

Work Schedule: M - F 8am - 5pm

• Process and evaluate AE reports according to standard operating procedures (SOPs): narrative, seriousness, causality, and expectedness assessment.
• Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment.
• Perform literature review for identification of case reports and other relevant safety information.
• Process, evaluate and support clinical trial activities as they relate to pharmacovigilance.
• Maintain an in-depth understanding of product knowledge and medical information publications, labeling, and relevant data for company products and maintain current awareness for the published literature.
• Act as the back-up for the PV Manager of NA.
• Support PV physician medical evaluations.
• Contribute to quality improvement of relevant SOPs: Review, prepare, and/or update local and global SOPs and working instructions as required.
• Interact with other departments (e.g. clinical development, quality, regulatory affairs, medical affairs) with regard to safety aspects.
• Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU,HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelor or Master level degree in Pharmacy, Pharmacology, RPh, RN, or degree in Public Health or Epidemiology is required.
• 8 or more years of relevant Pharmacovigilance or medical experience is required.
• Pharmacovigilance experience preferred, as is experience in nuclear medicine or similar industry.
• Knowledge of domestic and international laws, regulations, and policies governing pharmacovigilance.
• Ability to understand and interpret federal regulations and company operating procedures to determine whether the event constitutes a potential safety issue is required.
• Ability to critically evaluate the published medical and scientific literature and write and update comprehensive, medically accurate, and scientifically fair-balanced standard response documents for adverse events cases is required.
• Knowledge of Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, and Teams) required.
• Excellent written and verbal communication skills required.
• Must be able to prioritize and multi-task with minimal supervision and participate in peer- review process when processing medical inquires and product complaints.

Working Conditions:

• Must be willing to travel as needed.
• Willingness to work in a team based environment.
• Close attention to detail required.
• May be required to sit or stand for long periods of time while performing duties.
• Must be able to work outside of regular work hours.