Job Description
At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities, collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow. Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose.
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.
The base compensation range for this role in the posted location is: $112,600 - $212,700.
Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.
The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.
These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.
It is not typical for candidates to be hired at or near the top of the posted compensation range.
In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.
Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees. In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:
- 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
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. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.
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. We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. 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.
This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodation does not pose an undue hardship. Capgemini is committed to providing reasonable accommodation during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.
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Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.
Job Tags
Full time, Work at office, Local area, Visa sponsorship, Flexible hours,