Pharmacovigilance Audit and Inspection Readiness Manager
Location: Bridgewater, NJ
About the Job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Main Responsibilities:
- Participation in the ongoing permanent inspection preparedness and readiness of Global Pharmacovigilance (Patient Safety Pharmacovigilance-PSPV), Medical GBUs 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/Medical 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 and Medical processes/tools, Global PV vendors or Business Partner PV audits, until closure.
- Follow-up of audit/inspections PV/Medical-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 recurrence.
- Management of Business Partners PV Audits activity, in collaboration with external auditors and related PSPV.
- 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.
- Support completion of Health Authorities and Business partners pharmacovigilance risk assessment questionnaires to facilitate risk-based PV inspection planning.
About You:
- Bachelor’s degree Pharmacy (BS, RPh, Pharm D) or nursing (BSN, BScN) or biological science discipline. Advanced degree preferred.
- 7+ years of experience in global pharmaceutical industry, including experience in both post-marketing and clinical development activities.
- 5+ years of experience in Pharmacovigilance or clinical field, preferably in quality management activities.
- Experience working in a global environment, across diverse cultures.
Soft Skill & Technical Skills: Strong communication, problem solving, and leadership skills.
Languages: English required, Spanish a plus.
Why Choose Us?
- This role provides the opportunity to work at the forefront of digital innovation in the pharmaceutical industry.
- 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 good 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.
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Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.
About Us
Sanofi
Why Sanofi
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
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