Head Of Patient Safety France

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Position Summary
Leadership

• Represent Patient Safety as a member of the French Leadership Team and as key partner with the local/regional leadership and the local/regional business leads, and contribute to the overall goals of the local organization through effective collaboration with all stakeholders
• Lead, support and guide the Patient Safety Team in France and provide leadership on patient safety matters
• Hold primary responsibility and accountability for all country pharmacovigilance/patient safety activities.
• Health Authority nomination as safety contact as required
• Functional reporting to the Responsible Pharmacist (Chief Pharmaceutical Officer) and support requirements related to ‘French exploitant’ status and French regulatory requirements
• Represent BMS for safety related matters with the Health Authority and external partners/organizations, such as industry associations. Actively participate in negotiations, and discussions on safety related topics
• Maintain a strong open relationship with cross-functional stakeholders
• Drive awareness of patient safety regulations/requirements with all appropriate functional teams locally and globally
• Represent the country/region in collaboration with International and Global patient safety teams to build effective and efficient working practices
• Utilize an effective decision-making process, demonstrates strong judgment, decisiveness, and ability to balance the operational and strategic needs thereby enhancing the success of BMS in collaboration with concerned stakeholders
• Supervisory responsibilities as line manager for the local Patient Safety organization. Select and/or develop a dedicated team of Patient Safety professionals as necessary. Create a robust learning environment, leveraging shared experiences and promote best practice sharing as well as a culture of accountability, inclusion, innovation, and integrity
• Role model BMS values and behaviors with a strong focus on integrity and ethics
  

Compliance

• Endorse and implement a culture of compliance, act as a role model demonstrating consistent ethical and professional behavior
• Ensure adherence to all external and internal regulations and requirements
• Ensure audit/inspection readiness and lead cross-functional (local/regional) teams in collaboration with quality stakeholders and Patient Safety country leads to ensure effective conduct of audits/inspections
  

Position Responsibilities

• Risk management and risk minimization activities
• Provision of safety information
• Implementation of pharmacovigilance Audit and Inspection Readiness
• Planning, processing, and reporting of Aggregate Reports to HA and EC as applicable
• Maintenance of pharmacovigilance Awareness and Training
• Implementation of Pharmacovigilance Agreements and/or SAE Management plans
• Collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases as applicable
• Submission of single cases to local Health Agencies (HA) and Ethics Committees (as required)
• Local Market Safety Data Quality
  

Requirements

• Life Science University degree; Medicine or Pharmacy with appropriate country council registration (Conseil de l’Ordre des Médecins/des Pharmaciens)
• ≥ 10 years in the Pharmaceutical Industry, usually with at least 5 years’ experience working in Pharmacovigilance or in a closely aligned field in the respective country(ies)
• Line management experience
• Strong leadership and people management capability
• Ability to build effective working relationships with cross-functional teams
• Ability to develop excellent working relationship with the local HA or country HA liaison group/body where such opportunities exist
• Demonstrated skills in problem-solving, including in challenging and ambiguous situations
• Demonstrated ability to drive change and respond to changing environment
• Strong understanding of GxP and expert knowledge of local and global regulations specifically GVP requirements
• Clear understanding of the broader impact and possible implications on processes/the environment
• Demonstrated ability to negotiate difficult safety/compliance issues and influence internal and external partners
• Excellent communication skills (French and English)
• Minimal travel required in this position. Trips could include travel to BMS sites, Health Authorities and to attend professional meetings and seminars.
  

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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