Principal, Pharmacovigilance / Device Vigilance

Accountabilities:
The Principal, Pharmacovigilance / Device Vigilance will oversee safety surveillance activities for regulated diagnostic products, including laboratory-developed tests, in vitro diagnostic products, and software-driven medical technologies. The role requires strong regulatory expertise, analytical capabilities, and the ability to collaborate with diverse technical and medical stakeholders. Manage pharmacovigilance activities, including adverse event intake, triage, evaluation, documentation, and processing of Individual Case Safety Reports (ICSRs). Assess safety events related to diagnostic products, including clinical impact from incorrect, delayed, or misinterpreted results. Coordinate medical review, causality assessments, and timely submission of regulatory safety reports such as MedWatch, EudraVigilance, and CIOMS reports. Support aggregate safety reporting activities, including PSUR, PBRER, DSUR, and annual safety reports. Maintain compliance with global pharmacovigilance regulations, including FDA, EMA, ICH, and other international requirements. Lead device vigilance activities by reviewing complaints, evaluating reportability, and preparing medical device and post-market surveillance reports. Investigate software and algorithm-related safety events by partnering with engineering, laboratory, and data science teams to identify root causes and corrective actions. Contribute to risk management activities, including hazard analysis, risk files, and FMEA updates for integrated diagnostic systems. Ensure compliance with quality systems, SOPs, GVP requirements, and applicable medical device standards such as ISO 13485 and ISO 14971. Partner with Clinical, Regulatory Affairs, Quality, Medical Affairs, and operational teams to support audits, inspections, and continuous improvement initiatives. Maintain accurate safety documentation and support oversight of external vendors, CROs, and safety service providers. Provide timely support for urgent reporting requirements outside standard business hours when needed. Requirements: The ideal candidate is an experienced pharmacovigilance or device vigilance professional with a strong understanding of global safety regulations, healthcare technologies, and regulated product environments. They bring a detail-oriented mindset, strong communication skills, and the ability to manage complex safety programs independently. Bachelor’s degree in life sciences, biology, microbiology, chemistry, engineering, medical technology, regulatory science, or a related field required; advanced degree preferred. 12+ years of direct experience in pharmacovigilance, device vigilance, medical safety, or related regulatory functions. Strong knowledge of global safety regulations, including FDA, EMA, ICH, EU IVDR, and Japan regulatory requirements. Experience working with safety databases such as AEMS, Argus, ARISg, or Veeva Safety. Familiarity with MedDRA coding, case processing workflows, and safety reporting requirements. Knowledge of quality and risk management standards, including ISO 13485 and ISO 14971. Experience supporting diagnostic products, medical devices, or combination products preferred. Prior experience with regulatory audits, inspections, or compliance assessments preferred. Advanced degree credentials such as PharmD, MD, MPH, MSc, or certifications such as RAC or PV certification are a plus. Strong analytical and clinical assessment skills with excellent attention to detail. Ability to manage multiple priorities, complex projects, and changing business needs. Strong written and verbal communication skills, including the ability to collaborate with technical and medical teams across cultures. Self-motivated, proactive, and capable of exercising independent judgment in a regulated environment. Proficiency with Microsoft Office, Google Workspace, and relevant digital tools. Benefits: Competitive annual salary range of $160,700 - $200,850 USD for remote U.S. employees. Comprehensive medical, dental, vision, life, and disability insurance plans. Healthcare support programs, including family-focused benefits and fertility care resources. 401(k) retirement benefits and financial wellness programs. Paid parental leave and baby bonding leave. Commuter benefits and additional employee support programs. Employee referral incentives. Opportunities to work with multidisciplinary teams across healthcare, science, technology, and operations. A collaborative environment focused on innovation, inclusion, and meaningful impact on patient care.

How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
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