Sanofi Group Periodic Reports Expert in Swiftwater, Pennsylvania
The PRE Team are the experts on the regulatory requirements (GVP, ICH, CFR etc.) and process owners for the authoring global periodic safety reports (PSRs) coordinated by Global Pharmacovigilance (GPV).
The PRE Team is the GPV representative in inspections and audits responsible for explaining PSR authoring processes owned by the PRE Team.
The PRE is responsible for providing responses to Health Authority Assessment reports regarding PSR content in collaboration with the Global Safety Officer (GSO), Global Safety Sciences and Qualified Person for Pharmacovigilance (QPPV) when applicable.
Through content authoring and project management activities, the PRE ensures Global continuity of the safety messaging within PSRs across applicable regulatory submission documents (RMP, RSI) to support final approval and signature by the GSO/QPPV.
The PRE assures PSR submission compliance to global regulatory authorities by fostering productive and supportive relationships with internal participants (GSO, QPPV, Risk Management Office, Global Safety Sciences, System Support Unit) and PSR contributors external to GPV (Global Business Units, Medical functions, Global Regulatory Affairs, Biostatistics and Programming, Clinical Science Operations).
The PRE drives continuous improvement for periodic reporting processes and quality documents.
The PRE oversees vendors participating in periodic reporting activities, provides clear guidance on process expectations and productive feedback to ensure adherence to quality document requirements.
Knowledge And Skills
Proactive project management experience including multi-tasking of deliverables with competing timelines.
Flexibility to adapt to changing priorities and delays.
Fluency in ICH and GVP guidelines regarding periodic safety report content.
Comfortable leading cross-functional meetings in English.
Strong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environment.
Proficiency in Microsoft applications (Word, Power Point, Excel).
Formal Education And Experience Required
- PharmD with a minimum of 3 years of clinical or industry experience and 2 years minimum of Pharmacovigilance experience. Or BA/BS with a minimum of 4 years of industry experience and 2 years minimum of Pharmacovigilance experience.
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.