Senior Specialist I, Postmarketing Patient Safety and Pharmacovigilance Operations

Responsibilities Support oversight of drug safety/pharmacovigilance service providers to ensure adverse event collection, processing, reporting, and reconciliation in compliance with global regulatory requirements Perform in-line and/or end-of-line quality review of adverse event reports Create/revise department standard operating procedures and work instructions Develop and deliver training for safety-related topics Support process improvement initiatives and safety systems activities Support and participate in audits and inspections, including preparation activities Assist with safety operations and/or safety science activities and projects, as necessary Required Skills, Qualifications and Technical Proficiencies Ability to work in a dynamic environment to meet patient and corporate needs Knowledge of Argus (or similar safety applications) and MedDRA and WHO Drug coding dictionaries Excellent communication and collaboration skills Ability to manage multiple projects in a fast-paced environment Education and Experience Bachelor’s degree in healthcare or life sciences (RN/BSN; PharmD preferred) Minimum 3 years of Patient Safety & Pharmacovigilance experience in a global environment Experience in post‑marketing safety operations preferred Working knowledge of FDA, EU, and ICH guidelines for safety reporting and processing for clinical trials and post‑marketing Application instructions Applicants must be currently authorized to work in the United States on a full‑time basis. #J-18808-Ljbffr Scorpion Therapeutics