Sr Assoc Pharmacovigilance Operations

Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Submission of all individual case safety reports to FDA/EMA/BPs. Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Audit & external inspection support.