Sr. Pharmacovigilance Specialist/ Pharmacovigilance Specialist

Duties: 

·      Supports pharmacovigilance operations in the successful management of vendor and case processing deliverables in accordance with applicable regulations and agreements.

·      Interacts with case processing vendor on regular basis to ensure timely processing of adverse events reports for all investigational and/or marketed products.

·      Evaluates all adverse event reports received from the case processing vendor for accuracy and regulatory reporting criteria.

·      Performs vendor oversight activities by monitoring vendor's case processing quality and compliance metrics

·      Works closely with Regulatory personnel for regulatory submissions of adverse event reports.

·      Exercises independent judgment in managing case processing PV deliverables and maintaining compliance with SOPs, agreements and applicable worldwide regulations to ensure timely and consistent deliverables.

·      Supports development and maintenance of applicable SOPs, Working Practices and trainings.

·      Frequently interacts with collaborators, and functional peer groups at various management levels within and outside the organization to support vendor management and case processing deliverables.

·      Gather and analyze safety data for escalation. Facilitate correct and timely communication of safety issues.

·      Collates data for DSMBs.

·      Identify areas for improvement and deviations from process. Perform root cause analysis and initiate corrective and preventive action (CAPA) measures when appropriate.

Experience and Required Skills:

·      Working knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.

·      Subject Matter Expert for case processing. Knows when to escalate an issue and has the ability to apply critical thinking if timelines are at risk

·      Experience working in Argus Safety Database

Education & Experience:

·      Bachelor's level degree required. BSN highly preferred,

·      A minimum of 5 years’ experience in Drug safety or Pharmacovigilance.