This role centers on clinical review of adverse event reports and individual case safety reports, with a focus on case quality, completeness, seriousness, causality, and labeling considerations. It also includes broader pharmacovigilance compliance work such as supporting regulatory submissions, monitoring vendor performance, and improving safety case processing workflows. The position works closely with internal teams and external vendors to maintain timely, high-quality drug safety operations and documentation.
Key Responsibilities
- Review adverse event reports and ICSRs for completeness, validity, seriousness, causality, and labeling requirements.
- Perform clinical quality reviews of safety cases processed internally and by external vendors.
- Ensure timely case processing in the global safety database in accordance with SOPs and regulatory requirements.
- Monitor case quality trends, identify processing errors, and assess compliance risks.
- Prepare quarterly summaries and reports on quality trends and improvement opportunities.
- Develop and maintain SOPs, training materials, follow-up templates, and process documentation.
- Support regulatory submissions and compliance with FDA, EMA, ICH, and global pharmacovigilance requirements.
- Coordinate follow-up activities, data corrections, case reconciliation, and transmission verification.
Required
- Healthcare professional degree such as RN/BSN/MSN, NP, RPh, BPharm, PharmD, or MD.
- 5-7 years of pharmacovigilance experience in a biopharmaceutical environment, or equivalent clinical experience with strong drug safety knowledge.
- Strong understanding of ICSR processing, adverse event assessment, and pharmacovigilance compliance.
- Knowledge of FDA safety regulations, ICH guidelines, EMA regulations, and global PV requirements.
- Medical or scientific writing experience.
- Strong analytical, communication, documentation, and problem-solving skills.
Preferred
- Experience with clinical review and quality oversight of vendor-processed safety cases.
- Experience with global safety databases, case reconciliation, and regulatory submissions.
- Experience developing SOPs, training teams, and driving pharmacovigilance process improvements.