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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

pharmacovigilancesafety operationsICSR processingaggregate reportingsignal detectionsafety system administrationMedDRA codingnarrative writingdata miningregulatory submissions

Soft Skills

analytical skillsmedical writingcollaborationconsulting skillscapability assessmentgap identificationsolution recommendationstrong communication

Certifications

DSSCPPPharmDMDMSMPH