Capgemini Invent - LS Pharmacovigilance, Sr Consultant

About the 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.

Responsibilities

• Support safety operations, ICSR processing, aggregate reporting, signal detection, and safety system administration.
• Optimize safety systems like Argus, LifeSphere, and Vault Safety.
• Create and submit PSURs, PBRERs, DSURs, and annual safety reports.
• Manage risk assessments and ensure regulatory compliance with GVP, FDA, and ICH E2 guidelines.
• Use AI/ML to enhance pharmacovigilance practices.

Requirements

• Expert knowledge of PV regulations: FDA, EMA GVP, ICH E2.
• Direct experience with ICSR processing, MedDRA coding, and narrative writing.
• Practical use of safety databases and knowledge of E2B(R3).
• Experience with signal detection methods and data visualization tools.
• Strong analytical and medical writing skills.
• Collaboration with clinical, regulatory, medical, QA, and IT teams.
• Consulting skills: capability assessment, gap identification, solution recommendation.
• Mastery of Microsoft Office (Excel, PowerPoint, Word).

Qualifications

• Bachelor’s in life sciences, pharmacy, nursing, or related field; PharmD, MD, MS, MPH preferred.
• Eligible to work in the U.S. without visa sponsorship.
• Proficient with MedDRA and knowledge of WHO-DD.
• Understanding of E2B(R3) standards for electronic ICSR transmission.
• Experience in pharma/biotech PV operations and/or at CROs with PV services.
• Consulting experience in PV projects, regulatory inspections, and audit readiness.
• Experience with REMS programs, design, implementation, and 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 international PV regulations (PMDA, Health Canada, ANVISA, etc.).