Senior Specialist I, Postmarketing Patient Safety and Pharmacovigilance Operations

Responsibilities:
- Support oversight of drug safety/pharmacovigilance service providers to ensure collection, processing, reporting, and reconciliation of adverse event reports 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 or BSN, PharmD preferred)
- Minimum 3 years Patient Safety & Pharmacovigilance experience in a global environment
- Post-marketing safety operations experience preferred
- Working knowledge of FDA, EU, and ICH guidelines for safety reporting and processing for clinical trials and post-marketing