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CANDIDATES CAN BE BASED OUT OF THE NEW YORK METRO, CHICAGO, OR SAN FRANCISCO.

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 Life Sciences / Pharma clients' challenges of today and tomorrow. Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose.

The Life Sciences industry is undergoing dramatic changes, impacted by patent expirations, patient empowerment, increased regulatory scrutiny, and stringent cost containment. While the industry continues to lower costs and consolidate, it is seeking new growth opportunities through innovation, diversification, and expansion in emerging markets. Capgemini Invent’s Life Sciences practice has partnered with leading pharmaceutical and biotechnology clients to help define and deliver their future state for more than 25 years. The dedicated team guides clients from strategy to execution across the value chain. The practice’s core focus areas are **commercial and digital transformation, innovation, business agility, patient services, and patient experience** .

Skilled across the product lifecycle, the team brings deep experience in early commercialization, product launch, brand growth, and lifecycle management. The team’s consultants help drive change and transform organizations. Leaders in digital transformation, the team has helped clients establish innovation incubators, develop digital medicine strategies, enhance patient experiences, and identify new revenue sources.

YOUR ROLE

Scope & Responsibilities

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)

Project Management and Delivery

+ Support pharmacovigilance transformation projects by assessing safety processes, analyzing performance metrics, identifying compliance risks, and designing improved operating models.

+ Lead or support safety system implementations: requirements gathering, configuration, UAT, regulatory validation, training, and change management.

+ Conduct ICSR quality reviews, including 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: inspection readiness, mock walkthroughs, gap remediation, and CAPA implementation.

+ Analyze 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 like 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.

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.).

WHAT YOU’LL LOVE ABOUT WORKING HERE?

You’ll have the opportunity to:

+ Build a network within the Capgemini Group and contribute to the education of other Business Units around Life Sciences practice offerings to support existing account expansion

+ 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 an Equal Opportunity Employer encouraging diversity in the workplace. 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 accommodations do not pose an undue hardship._

_Click the following link for more information on your rights as an Applicant:_ _http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law_

ABOUT CAPGEMINI

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, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion.

Job:

**Organization:** _INVENT PEOPLE S&T_

**Title:** _Capgemini Invent – Senior Consultant – Life Sciences; Pharmacovigilance (R&D)_

**Location:** _NY-New York_

**Requisition ID:** _082756_

**Other Locations:** _US-IL-Chicago, US-CA-San Francisco_