Pharmacovigilance and Patient Safety Manager

What You'll Do:

• Monitor CROs and business partners for compliance with Safety Monitoring Plans, study plans, metrics, KPIs, and contractual agreements
• Lead pharmacovigilance (PV) compliance, inspection, and audit readiness for Argus, KPIs, and safety management topics.
• Oversee ICSR workflow, case management activities in Argus (or other safety databases), ensuring critical timelines and compliance
• Provide pharmacovigilance oversight for clinical trials, post-market surveillance, and expanded access programs, ensuring integration of safety data
• Perform peer review of cases in safety databases, including adverse event coding, report tracking, and regulatory reporting as needed
• Triage incoming cases, assess seriousness, expectedness, and causality, and write high-quality case narratives for medical review
• Stay updated on regulatory requirements for safety management in Expanded Access and Compassionate Use Programs (EAPs/CUPs)
• Produce and submit safety reports (e.g., CIOMS/MedWatch Forms) to regulatory authorities, ensuring compliance with timelines
• Support the commercial team by participating in client calls, reviewing proposals, budgets, and presenting at bid defense meetings
• Act as system administrator for the company's global safety database (Argus), overseeing vendor relationships, system maintenance, and training

What You'll Need:

• Bachelor’s Degree in a Science or related field required; advanced degree (PharmD, MD, etc.) strongly preferred
• Experienced in drug safety/pharmacovigilance role in the biotech/pharmaceutical industry and/or in a CRO or clinical trial setting
• Proficient with International Council for Harmonization (ICH) Good Clinical Practices (GCP) guidelines and other applicable regulatory rules and guidelines, as well with medical terminology, clinical trials and clinical research
• Familiarity with and ability to effectively utilize safety databases needed. Knowledge of Argus Safety Database in an administration capacity is preferred
• Action-oriented and resilient in a fast-paced environment with strong project team skills and ability to mentor, delegate and motivate others
• Ability to communicate effectively with clients, internal teams and vendors and soft skills to build and maintain trust and confidence
• Strong understanding of global safety regulations, medical terminology, and drug development process
• Strong clinical background, with ability to interpret medical records (e.g., laboratory results, medical records) is a plus