Head of Patient Safety France

Il y a 6 mois

RueilMalmaison, France Bristol-Myers Squibb Temps plein

**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.

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 t

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