Deputy Country Safety Head, US/Canada
Deputy Country Safety Head, US / Canada
Location: Bridgewater, NJ
Job Type: Full time
About the Job
At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.
In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.
Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.
We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.
We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.
The performance of the DCSH is of high importance as these roles are mandated by local legislation and within the scope of local PV inspections. The Deputy CSH must be ready to deputize for the CSH at any time and may be exposed to GxP inspections standing in the first line (e.g. unannounced inspections during a time of absence of the CSH).
The CHC PV Deputy Country Safety Head (DCSH)
- Supports the Country Safety Head in country related PV activities.
- Deputizes for the CSH in times of planned or unplanned absence of the CSH.
- Is nominated as deputy local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations.
- Supports the CSH in ensuring that local PV activities in the assigned country are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country.
- Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager.
Organization and Maintenance of Local PV Quality System
- Support the maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements.
- Support the maintenance of the local PV System Master File for the assigned country as required and in accordance with local regulations and the global standards.
- Contribute to education and training on PV and relevant safety topics within the local organization.
- Maintain local compliance metrics and ensure data capture in the appropriate tools.
- Support PV process non-compliance investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation including appropriate documentation.
- Support the completion of audit and inspection observations in close interaction with Global /Local Functions
Organization and Maintenance of PV Operating & Safety Management System
In compliance with PV regulatory requirements and company procedures/guidelines,
- Monitor continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to Global PV Operations and subsequently to external stakeholders, such as HAs, partners.
- Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with Global PV, Clinical Operations and RA departments to the planning for PSRs,.
- Screen local scientific / medical literature and management of relevant abstract/articles.
- Support the implementation and monitor the PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program...), and company sponsored digital media.
- Contribute to screening and analysis of national regulations, and forward any future/new/updated PV regulation as per defined processes.
- In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), support the monitoring of the appropriate execution of outsourced activities.
- Support the Global PV and particularly the QPPV with local safety surveillance activities.
- Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert. Track the actual implementation of additional Risk Minimization Measures (aRMMs) in the assigned country.
Key Working Relationships
- PV CSH
- PV Zone Leads
- Regional PV Head
- Country Medical/Regulatory/Quality Teams and Country Manager
- Global PV Operations Team
- Global Medical Safety Team
- Network of PV Zone Leads and CSHs
- Robust understanding of national PV regulations regarding safety requirements.
- Pragmatic, solution oriented mindset; problem-solving, prioritize, detail-oriented, and meet challenges.
- Good written and verbal communication skills. Good level of speaking/writing English.
- Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master's Degree with two or more years of pharmacovigilance experience.
- Experience with pharmacovigilance systems and safety related product management.
Cultural traits / P2W Behavior
- Push to go beyond the level we have operated until now: constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment.
- Put the interest of the organization ahead of own of those of his/her team: consider both short and long term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level.
- Act in the interest of our patients and customers: actively engage with customers to know their current and future needs; brings the local perspective into decision making.
- Required Leadership Competencies.
- Interpersonal relationships - treating others with courtesy, sensitivity, and respect.
- Change Leadership - The ability to demonstrate support and drive for innovation and organizational transformation.
- Personal Leadership - Personal leadership translates into courage, choice, and commitment through the pursuit of excellence, trust, and accountability. Ability to put patient, stakeholder, and organizational interests above personal interests.
- Desire and need to achieve challenging goals, to improve performance or to meet personal standards of excellence.
- Learning Agility – Ability to navigate first time/unfamiliar situations effectively by extrapolating from other areas of expertise and knowledge. Ability to continuously improve and develop.
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, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
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.