Capgemini
Capgemini Invent – Senior Consultant – Life Sciences; Pharmacovigilance (R&D)
Capgemini, New York, New York, us, 10261
Capgemini Invent – Senior Consultant – Life Sciences; Pharmacovigilance (R&D)
Join Capgemini Invent to drive pharmacovigilance transformation across the Life Sciences industry. Work in New York, NY; Chicago, IL; or San Francisco, CA.
Scope & Responsibilities As a Senior Consultant, you will act as a pharmacovigilance and drug safety expert for pharmaceutical and biotech clients. Your responsibilities include:
Consulting on pharmacovigilance and drug safety for Life Sciences clients.
Optimising safety systems (Argus, LifeSphere, Vault Safety).
Preparing aggregate safety reports (PSURs, PBRERs, DSURs).
Conducting signal detection, risk management, and ICSR processing.
Ensuring safety compliance with GVP, FDA, and ICH E2 guidelines.
Project Management and Delivery
Assess safety processes, analyse performance metrics, identify compliance risks, and design improved operating models.
Lead or support safety system implementations, including requirements gathering, configuration, UAT, regulatory validation, training, and change management.
Conduct ICSR quality reviews covering narrative accuracy, causality assessments, coding, reportability, and compliance checks.
Assist with preparation of aggregate safety reports by compiling data, performing analyses, and drafting report sections.
Conduct signal detection using statistical and data‐review methods and recommend risk mitigation.
Assess REMS programs, identify gaps, and recommend improvements.
Support safety compliance activities: inspection readiness, mock walkthroughs, gap remediation, and CAPA implementation.
Analyse safety data to support clinical development and regulatory submissions (ISS, safety tables, benefit–risk assessments).
Evaluate safety data exchange processes and ensure data quality (E2B(R3) submissions, sponsor/CRO reconciliation).
Create client deliverables: SOPs, process documents, system specifications, quality reports, and strategic recommendations.
Business Development
Contribute pharmacovigilance content for client proposals and solution strategies.
Participate in workshops to assess client needs and position Capgemini expertise.
Identify cross‑sell opportunities during other client engagements.
Building Our Brand
Develop reusable pharmacovigilance tools and frameworks (e.g., maturity models, checklists, methodologies).
Stay updated on global PV regulations (FDA, EMA GVP, ICH E2) and new trends such as AI/ML and real‑world evidence.
Contribute to thought leadership on innovative PV topics and best practices.
People Development
Mentor peers and junior consultants in PV concepts, regulations, and best practices.
Support recruiting by interviewing and evaluating PV candidates.
Contribute to internal PV training programs.
Required Skills and Experience
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 (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 judgement).
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.).
What You’ll Love About Working Here
Build a network within the Capgemini Group and contribute to the education of other Business Units around Life Sciences practice offerings.
Play a significant role in client proposals and RFI/RFP responses from initial brief to final sales presentations.
Nurture and expand existing account relationships.
Identify potential personal business relationships that can be leveraged by the practice to develop new business.
Identify potential project extension and expansion opportunities while staffed on projects.
Support the development of thought leadership and innovative offerings as they relate to AI/Data Science, Digital Customer Analytics, and Operational Analytics.
Support the upskilling of the Life Sciences team members on topics related to Data & Analytics.
Capgemini is a global business and technology transformation partner, helping organizations accelerate their dual transition to a digital and sustainable world. With a responsible and diverse group of 340,000 team members in more than 50 countries, Capgemini unlocks the value of technology to address the entire breadth of business needs.
Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment regardless of race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status, or any other characteristic protected by law.
Click the following link for more information on your rights as an applicant: http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law
Base salary range for the tagged location is $120,000 to $150,000. This role may be eligible for additional compensation including variable compensation, bonus, or commission. Full‑time regular employees are eligible for paid time off, medical/dental/vision insurance, 401(k), and other benefits.
Schedule Full‑time
Primary Location US‑NY – New York
Other Locations US‑IL – Chicago, US‑CA – San Francisco
Organization INVENT PEOPLE S&T
#J-18808-Ljbffr
Scope & Responsibilities As a Senior Consultant, you will act as a pharmacovigilance and drug safety expert for pharmaceutical and biotech clients. Your responsibilities include:
Consulting on pharmacovigilance and drug safety for Life Sciences clients.
Optimising safety systems (Argus, LifeSphere, Vault Safety).
Preparing aggregate safety reports (PSURs, PBRERs, DSURs).
Conducting signal detection, risk management, and ICSR processing.
Ensuring safety compliance with GVP, FDA, and ICH E2 guidelines.
Project Management and Delivery
Assess safety processes, analyse performance metrics, identify compliance risks, and design improved operating models.
Lead or support safety system implementations, including requirements gathering, configuration, UAT, regulatory validation, training, and change management.
Conduct ICSR quality reviews covering narrative accuracy, causality assessments, coding, reportability, and compliance checks.
Assist with preparation of aggregate safety reports by compiling data, performing analyses, and drafting report sections.
Conduct signal detection using statistical and data‐review methods and recommend risk mitigation.
Assess REMS programs, identify gaps, and recommend improvements.
Support safety compliance activities: inspection readiness, mock walkthroughs, gap remediation, and CAPA implementation.
Analyse safety data to support clinical development and regulatory submissions (ISS, safety tables, benefit–risk assessments).
Evaluate safety data exchange processes and ensure data quality (E2B(R3) submissions, sponsor/CRO reconciliation).
Create client deliverables: SOPs, process documents, system specifications, quality reports, and strategic recommendations.
Business Development
Contribute pharmacovigilance content for client proposals and solution strategies.
Participate in workshops to assess client needs and position Capgemini expertise.
Identify cross‑sell opportunities during other client engagements.
Building Our Brand
Develop reusable pharmacovigilance tools and frameworks (e.g., maturity models, checklists, methodologies).
Stay updated on global PV regulations (FDA, EMA GVP, ICH E2) and new trends such as AI/ML and real‑world evidence.
Contribute to thought leadership on innovative PV topics and best practices.
People Development
Mentor peers and junior consultants in PV concepts, regulations, and best practices.
Support recruiting by interviewing and evaluating PV candidates.
Contribute to internal PV training programs.
Required Skills and Experience
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 (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 judgement).
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.).
What You’ll Love About Working Here
Build a network within the Capgemini Group and contribute to the education of other Business Units around Life Sciences practice offerings.
Play a significant role in client proposals and RFI/RFP responses from initial brief to final sales presentations.
Nurture and expand existing account relationships.
Identify potential personal business relationships that can be leveraged by the practice to develop new business.
Identify potential project extension and expansion opportunities while staffed on projects.
Support the development of thought leadership and innovative offerings as they relate to AI/Data Science, Digital Customer Analytics, and Operational Analytics.
Support the upskilling of the Life Sciences team members on topics related to Data & Analytics.
Capgemini is a global business and technology transformation partner, helping organizations accelerate their dual transition to a digital and sustainable world. With a responsible and diverse group of 340,000 team members in more than 50 countries, Capgemini unlocks the value of technology to address the entire breadth of business needs.
Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment regardless of race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status, or any other characteristic protected by law.
Click the following link for more information on your rights as an applicant: http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law
Base salary range for the tagged location is $120,000 to $150,000. This role may be eligible for additional compensation including variable compensation, bonus, or commission. Full‑time regular employees are eligible for paid time off, medical/dental/vision insurance, 401(k), and other benefits.
Schedule Full‑time
Primary Location US‑NY – New York
Other Locations US‑IL – Chicago, US‑CA – San Francisco
Organization INVENT PEOPLE S&T
#J-18808-Ljbffr