Capgemini Invent - LS Pharmacovigilance, Sr Consultant
Capgemini Invent, New York, NY, United States
Capgemini Invent - LS Pharmacovigilance, Sr Consultant
at Capgemini Invent
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 Required
6–10 years of 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); vacation: 12‑25 days, 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.
Compensation The base compensation range for this role in the posted location is: $112,600 – $212,700.
Work Arrangements Hybrid working. Capgemini’s Flex Abroad program allows employees to work abroad for up to 45 days in a 12‑month period.
Important Notice Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini’s discretion, consistent with applicable laws.
Disclaimers Capgemini is an Equal‑Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion, and respect. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status, or any other characteristic protected by law.
Important Notice Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.
Company Overview Capgemini is a global business and technology transformation partner, helping organizations accelerate their digital and sustainable transition while creating tangible impact for enterprises and society. With more than 50 countries and 340,000 team members, Capgemini delivers end‑to‑end services and solutions leveraging strengths from strategy and design to engineering, powered by AI, cloud, and data expertise.
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at Capgemini Invent
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 Required
6–10 years of 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); vacation: 12‑25 days, 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.
Compensation The base compensation range for this role in the posted location is: $112,600 – $212,700.
Work Arrangements Hybrid working. Capgemini’s Flex Abroad program allows employees to work abroad for up to 45 days in a 12‑month period.
Important Notice Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini’s discretion, consistent with applicable laws.
Disclaimers Capgemini is an Equal‑Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion, and respect. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status, or any other characteristic protected by law.
Important Notice Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.
Company Overview Capgemini is a global business and technology transformation partner, helping organizations accelerate their digital and sustainable transition while creating tangible impact for enterprises and society. With more than 50 countries and 340,000 team members, Capgemini delivers end‑to‑end services and solutions leveraging strengths from strategy and design to engineering, powered by AI, cloud, and data expertise.
#J-18808-Ljbffr