POSITION SUMMARY:

The Principal, Pharmacovigilance / Device Vigilance is a detail-oriented and proactive professional supporting the safety surveillance of In Vitro Diagnostic and Software-driven products across their lifecycle, including clinical studies and post-market activities. This role is responsible for the collection, assessment, reporting, and management of adverse events, product complaints, and safety data for both medicinal products and medical devices, ensuring compliance with global regulatory requirements.

The position plays a critical role in ensuring compliance with global regulatory requirements (e.g., FDA, EU IVDR, Japan) and maintaining the highest standards of patient safety and product quality across both laboratory-developed tests and regulated IVD products, including software/algorithm-based components.

PRIMARY RESPONSIBILITIES:

• Pharmacovigilance (Drug Safety)

  • Perform case intake, triage, and processing of Individual Case Safety Reports (ICSRs)

  • Process and evaluate adverse events associated with diagnostic use (e.g., clinical impact of false positives/negatives)

  • Coordinate medical review and causality assessment of adverse events

  • Coordinate timely submission of safety reports (e.g., MedWatch, EudraVigilance, CIOMS)

  • Support aggregate reporting (PSUR/PBRER, DSUR, annual reports)

  • Maintain and ensure compliance with global PV regulations (FDA, EMA, ICH, etc.)

  • Contribute to signal detection and risk management activities

• IVD Device Vigilance

  • Review, triage, and assess product complaints and adverse events related to genetic and diagnostic testing, including incorrect, delayed, or misinterpreted results

  • Evaluate reportability of events under FDA (MDR), EU IVDR vigilance, Japan and other global regulations

  • Prepare and submit Medical Device Reports (MDRs) and vigilance reports within regulatory timelines

  • Collaborate with laboratory operations, bioinformatics, and software teams to investigate root cause (e.g., assay performance, variant interpretation, software defects)

  • Support post-market surveillance activities, including trending, signal detection, and periodic safety reporting

• Software & Algorithm-Related Safety

  • Assess safety events associated with software as part of a medical device system, including algorithm errors, data processing issues, and reporting inaccuracies

  • Partner with engineering and data science teams to evaluate software-related complaints and implement corrective actions

  • Contribute to risk management activities (e.g., hazard analysis, risk files, FMEA updates) for software and integrated diagnostic systems

• Cross-Functional & Compliance

  • Ensure compliance with SOPs, GVP, and applicable quality systems (QMS)

  • Partner with Clinical, Regulatory Affairs, Quality, and Medical Affairs teams

  • Support audits and inspections (internal and external)

  • Maintain accurate documentation in safety databases

  • Assist in vendor oversight (e.g., CROs, safety service providers)

  • Other duties as assigned

  • Ability to provide support outside of standard business hours for expedited reporting requirements as needed

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QUALIFICATIONS:

• Required

  • Bachelor’s degree in life science field (biology, microbiology, chemistry, engineering, medical technology, regulatory science, etc.) or equivalent. Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred.
    RAC preferred.
    Minimum of 12 years of direct applicable experience in pharmacovigilance and/or device vigilance

  • Strong knowledge of global safety regulations (FDA, EMA, ICH, EU IVDR, Japan)

  • Experience with safety databases (e.g., AEMS, Argus, ARISg, Veeva Safety)

  • Familiarity with MedDRA coding and case processing workflows

  • Knowledge of applicable standards, including ISO 13485 and ISO 14971

• Preferred

  • Advanced degree (PharmD, MD, MPH, MSc)

  • Experience in diagnostics or combination products

  • Prior audit/inspection experience

  • RAC, PV certification, or similar credentials

KNOWLEDGE, SKILLS, AND ABILITIES:

• Experience with global markets is highly desirable

• Strong analytical and clinical assessment skills

• Attention to detail and regulatory compliance mindset

• Ability to manage multiple priorities and deadlines

• Excellent written and verbal communication

• Cross-functional collaboration

• Demonstrated self-starter and highly motivated, energetic and enthusiastic.

• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices, which includes analytical problem solving.

• Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results.

• Ability to be effective in complex projects with ambiguity and/or rapid change

• Excellent written and verbal communication skills including ability to communicate across cultures

• work with others in a team environment; effective interactions with technical and medical personnel.

• Computer literacy (PC, Microsoft Office and Google Workspace).