Drug Safety Specialist

Key Responsibilities:
- Participate in Adverse Event/Serious Adverse Event processing and reconciliations by outsourced vendors, including review of Individual Case Safety Report (ICSR) processing (case triage, data entry, coding review, sponsor approval, narrative writing) and monitor ICSR reporting within the Company Sponsored Safety Database.
- Support monitoring of vendor quality for ICSR processing for clinical and post-marketing cases.
- Support monitoring and performing notifications and/or submissions for individual cases.
- Distribute safety reports to the clinical team; maintain the master contact list; oversee IST reconciliation.
- Perform QC of SAE and non-serious AE cases as part of vendor oversight.
- Assist with organization and preparation for FDA audit.
- Prepare gap packs for clinical sites.
- Perform additional safety-related duties as assigned.

Qualifications:
- Bachelor’s degree in nursing, pharmacy, or other health care related profession, or life sciences.
- Minimum 3 years of Drug Safety/Pharmacovigilance case processing in a pharmaceutical industry setting.
- Previous experience with ICSR workflow steps and safety database (Argus preferred), MedDRA coding, and data entry conventions.
- Experience with Argus safety databases, EDC systems, and electronic document management systems.
- Global pharmacovigilance operations experience with products in development.
- Knowledge of ICH Good Pharmacovigilance Practices and Good Clinical Practices; GCPs, GVPs, FDA/EMA/ICH guidelines, and international regulations.
- Strong analytical skills and attention to detail; ability to prioritize urgent deliverables.
- Strong verbal/written technical communication and presentation skills.
- Ability to work effectively and collaboratively in a fast-paced team environment.

Benefits:
- Base salary range: $89K–$110K; eligible for annual bonus, equity compensation, and a competitive benefits package.