Hybrid Senior Consultant – LS Pharmacovigilance

at Minor Hotels Europe and Americas

• Job title: Senior Consultant – LS Pharmacovigilance
• Job type: Full Time
• Experience level: Senior
• Salary: $112,600 - $212,700 per year
• Degree requirement: Bachelor's Degree
• Tech skills: C++, Tableau, Vault
• Location requirements: Hybrid, New York City, United States

About the role

• Senior Consultant driving pharmacovigilance and drug safety solutions for pharmaceutical and biotech clients. Collaborating on safety operations, compliance, and integrating innovative technologies.

Responsibilities

• Act as a pharmacovigilance and drug safety expert for pharmaceutical and biotech clients
• Support safety across the product lifecycle - from clinical development to post-market
• Collaborate with Principals and Managers on projects such as safety system implementations, process optimization, aggregate safety reporting, signal detection, risk management, and regulatory compliance
• Work with varied product types (small molecules, biologics, vaccines, advanced therapies)
• Integrate AI/ML into pharmacovigilance practices

Requirements

• 6–10 years hands-on pharmacovigilance experience in safety operations, ICSR processing, aggregate reporting, signal detection, or safety system administration
• Expert knowledge of PV regulations: FDA (21 CFR 312.32, 314.80, FAERS), EMA GVP (Modules VI, VII, IX), and ICH E2 (E2A-E2F)
• Direct experience with ICSR processing: intake, triage, medical review, causality assessment (WHO-UMC, Naranjo), MedDRA coding, narrative writing, and regulatory submissions
• Practical use of safety databases (e.g., Argus, LifeSphere, Vault Safety, IQVIA Vigilance, AB Cube)
• Experience with aggregate safety reports: PSURs/PBRERs, DSURs, Annual Safety Reports, and benefit-risk analysis
• Knowledge of signal detection methods (statistical/data mining, literature review, clinical judgment)
• Bachelor’s in life sciences, pharmacy, nursing, or related field; advanced degree (PharmD, MD, MS, MPH) preferred
• Eligible to work in the U.S. without visa sponsorship
• Proficient with MedDRA (coding, conventions, versioning) and knowledge of WHO-DD
• Understanding of E2B(R3) standards for electronic ICSR transmission (FAERS, EudraVigilance)
• Strong analytical and medical writing skills (narratives, signal evaluation, safety reports)
• Proven ability to collaborate with clinical, regulatory, medical, QA, and IT teams
• Consulting skills: capability assessment, gap identification, solution recommendation
• Mastery of Microsoft Office (Excel, PowerPoint, Word)
• Preferred: Clinical background (MD, PharmD, RN, PA)
• PV certification (DSS, CPP, or equivalent)
• Experience in pharma/biotech PV operations and/or at CROs with PV services
• Consulting experience (Big 4 or life sciences consultancies) in PV projects
• Involvement in regulatory inspections (FDA/EMA GVP), and audit readiness
• Experience with REMS programs (design, implementation, assessment)
• Knowledge of specialty product safety (biologics, vaccines, oncology, gene/cell therapies, ATMPs)
• Familiarity with real-world evidence for safety (claims databases, EHR, registries, social media)
• Understanding of AI/ML in PV (NLP, signal detection, predictive analytics, workflow automation)
• Experience with data visualization tools (Tableau, Spotfire, Power BI)
• Exposure to international PV regulations (PMDA, Health Canada, ANVISA, etc.)

Benefits

• Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade
• Company paid holidays
• Personal Days
• Sick Leave
• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• Other benefits as provided by local policy and eligibility