Drug Safety Associate

Job Description

• Supervise or perform the periodic reconciliation of safety report information between the drug safety database and local PV representatives (PQC, CRO, Data Management, LSM, etc.)
• Management and oversight of PV vendor(s) regarding intake and reconciliation activities
• Support the management and oversight of Case Management Mailboxes and other sources of intake for ICSR processing
• Support PV management in the oversight of vendor-supported ICSR intake/processing
• Perform and/or oversee the collection and follow-up processes of adverse event (AE) reports from clinical trials and post-marketing sources
• Coordinate internally and with external pharmacovigilance providers (CROs) and Business Partners on Drug Safety and Pharmacovigilance case management issues
• Participate in training activities related to Case management
• Support PV Management with Call Center Business related activities (oversight, training, reconciliation)
• Support PV management in investigation, root cause, corrective and preventive actions related to internal and external PV-associated CAPA findings
• Maintains a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations.
• Serve as PV SME for associated projects/product related meetings/committees
• Assist in the generation of database queries for AE listings
• Support technology-related projects such as safety database upgrades, and implementation of new case processing and intake tools.
• This may include the need for case processing activities including but not limited to: Triage, Data Entry, Assessment, Quality Review, query generation, manufacturer notifications, and coding. Tasks may include a review of source information, MedDRA coding, narrative preparation, preliminary seriousness, causality and listedness assessments, case corrections, and listing reviews.
• Participate in User Acceptance Testing activities for Case Management Initiatives
• Perform assigned PV-related activities in accordance with Otsuka Standard Operating Procedures, and regulatory requirements.
• Support guidance document development and updates including but not limited to PVAs, SMPs, SOPs, and other guidance/training documents
• Lead and provide safety operations support on assigned studies
• Support PV Inspection/Audit activities or Health Authority requests
  
  

Company Description

APCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory, and technology resources to ensure that patients receive the safest, most effective therapies possible.

APCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory, and technology resources to ensure that patients receive the safest, most effective therapies possible.