Job Description
Job Title: Pharmacovigilance Audit and Inspection Readiness Expert Location: Morristown, NJ
About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Pharmacovigilance Audit and Inspection Readiness team as an Expert.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities: - Participation in the ongoing permanent inspection preparedness and readiness of Patient Safety and Pharmacovigilance (PSPV) and country PV offices in anticipation of regulatory inspections and audits.
- Active involvement in the preparation, conduct, and follow-up of GxP regulatory inspections impacting PV until closure.
- Active involvement in the organization of appropriate support for the preparation, conduct, and follow-up of Global Quality audits impacting country GxP activities, global PV processes/tools or Business Partner audits, until closure.
- Follow-up of audit/inspections of PV-related Corrective and Preventive Actions (CAPAs) to ensure timely completion and coordination of CAPA effectiveness reviews in collaboration with CAPA owners, as needed to prevent a recurrence.
- Management of Business Partners and Global Service Providers PV Audits activity, in collaboration with external auditors and related GPV functions.
- PV Quality Liaison role for Country Safety Heads / Multi-Country Safety Heads for an assigned group of countries by providing Quality oversight across countries on the country PV deliverables and highlighting PV Quality risks, issues and mitigation plan(s) to the Regional PV / Quality Heads.
- Support in external relations with Inspectorates / Agencies / Pharma associations / Inter-Company network to ensure surveillance of PV inspections regulations/practices and benchmark on recurrent PV findings.
About You EDUCATION AND EXPERIENCE - Bachelor’s or higher in Pharmacy (BS, RPh, Pharm D) or Bachelor’s or higher in nursing (BSN, BScN) or biological science discipline (Biology, Health Sciences...).
- A minimum of 5 years of experience in Pharmacovigilance or clinical field, preferably in quality management activities.
- A minimum of 7 years of experience in the global pharmaceutical industry, including experience in both post-marketing and clinical development activities.
- Experience working in a global environment, across diverse cultures.
PROFILE - Capability to work under extreme pressure.
- Excellent communication skills (oral and written).
- Excellent organizational and planning capabilities.
- Ability to work in transversal/cross-functional teams.
- Excellent teamwork and interpersonal skills.
- Ability to take initiative and overcome challenges.
- Ability to interact with inspectorates from Health Authorities in a constructive manner.
- Excellent knowledge of International (ICH/CIOMS), EU (Good PV practices), and FDA regulations in the domain of Pharmacovigilance.
- Fluent in Spanish is preferred to work with LATAM country inspections
Why Choose Us? - Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take safe care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Tags
Permanent employment,