Senior Director – Pharmacovigilance, PV Operations
Implaion Recruiting
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Play a pivotal role in commercialization of their first product
- Provide pharmacovigilance leadership and oversight
- Prepare for and lead FDA inspections
- Ensure alignment of safety strategy across departments
- Build and scale pharmacovigilance systems from early-stage to commercial readiness
- Establish and maintain inspection-ready documentation
- Manage safety vendors and ensure compliance
Requirements
- Extensive pharmacovigilance leadership experience in small-molecule therapeutics, ideally in autoimmune or immunology indications
- Direct, hands-on experience preparing for and leading FDA pharmacovigilance inspections (pre-approval inspections in particular)
- Demonstrated ability to sit opposite FDA investigators and defend safety systems, processes, and decisions with clarity and confidence
- Deep expertise in case processing operations, including oversight of vendors, safety databases, workflow design, quality control, and compliance metrics
- Prior responsibility for building or scaling PV systems from early-stage to commercial readiness, including SOP development and governance
- Strong understanding of safety aggregate reporting (DSURs, PADERs, periodic benefit-risk evaluations) and how these are audited during inspections
- Proven track record establishing inspection-ready documentation, end-to-end safety process maps, and evidence packages for regulators
- Experience interacting cross-functionally with clinical development, regulatory affairs, quality, and medical affairs to ensure alignment of safety strategy
- Knowledge of NDA requirements for safety sections (Module 2.7.4 and Module 5 safety data organization) and how FDA interrogates these materials
- Ability to manage and oversee safety vendors, ensuring compliance, audit findings resolution, and operational readiness
- Familiarity with signal detection methodologies and benefit-risk assessments relevant to NDA submissions
- Experience training teams for mock inspections and serving as a primary point of contact during actual inspections
- Strong operational mindset with the ability to implement scalable PV infrastructure for a company preparing its first commercial launch.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacovigilancecase processing operationssafety databasesworkflow designquality controlcompliance metricssafety aggregate reportingsignal detection methodologiesbenefit-risk assessmentsSOP development
Soft skills
leadershipcommunicationcross-functional collaborationclarityconfidenceoperational mindset