Your Role

As a Senior Consultant, you will act as a pharmacovigilance and drug safety expert for pharmaceutical and biotech clients, supporting safety across the product lifecycle - from clinical development to post-market. You?ll collaborate with Principals and Managers on projects such as safety system implementations, process optimization, aggregate safety reporting, signal detection, risk management, and regulatory compliance. This role offers opportunities to work with varied product types (small molecules, biologics, vaccines, advanced therapies) and integrate AI/ML into pharmacovigilance practices.

Key Focus Areas

Pharmacovigilance and drug safety consulting for Life Sciences clients
Safety system optimization (e.g., Argus, LifeSphere, Vault Safety)
Aggregate safety reporting (PSURs, PBRERs, DSURs)
Signal detection, risk management, and ICSR processing
Safety compliance (GVP, FDA, ICH E2 guidelines)

Qualifications & Experience

Skills and Experience

Required:

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.).

Short Description

At Capgemini Invent, we empower our people to explore, innovate, and progress. As a global community of entrepreneurial thinkers, you?ll be encouraged to step up, try new things, and make a mark. As part of Capgemini Invent, you?ll have the flexibility to work your own way and find your balance. We give you the ownership and support you need to grow your skills and shape your future path.

Hybrid working

We believe that flexibility is the key to a healthy work-life balance. That?s why our employees work with their managers to determine an arrangement that works best for their role and personal circumstances.

Flex abroad

Capgemini?s Flex Abroad program gives employees the opportunity to work abroad for up to 45 days in a 12-month period. This allows you to temporarily change your working environment while staying connected to your team and career goals.