Senior Manager, Patient Safety, Distributor Markets

Job content

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.Position Summary / ObjectiveLeadership

• Holds responsibility for oversight of all Patient Safety activities performed by the Distributor
• Plans, develops and communicates local WWPS strategy and expected operationalisation to Distributor on safety related activities (including for example RM activities, HA connectivity, contracts and quality management issues) so as to meet agreed performance
• Liaises with Distributor and Leads and represents BMS on safety related matters with the Health Authority and external partners/organisations such as industry associations, and actively participates in negotiations and discussions on safety related topics.
• Ensures oversight of agreed Distributor KPI in collaboration with QST
• Maintain a strong and open relationship with cross-functional stakeholders related to: the provision of guidance on pharmacovigilance requirements, to ensure compliance of the Distributor and safety related considerations are analysed, evaluated and resolved as necessary
• Represents the LR country in collaboration with Regional and Global patient safety teams to build effective and efficient working practices.
• Utilizes 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 global stakeholders.
• Supervisory responsibilities as line manager as required
• Compliance
• Endorse and implement a culture of compliance, act as a role model demonstrating consistent ethical and professional behaviour
• Collaborate with Distributor as necessary on audit/inspection readiness and supports cross-functional teams in collaboration with quality stakeholders to ensure effective conduct of audits/inspections for Distributors

Position Responsibilities

• Oversight of Distributor activities as defined in PVAs.
• This may include oversight of:
• Risk management plans and risk minimisation activities.
• Provision of safety information
• Implementation of pharmacovigilance Audit and Inspection Readiness
• Planning, processing and reporting of Aggregate Reports to HA and EC (as required)
• Maintenance of pharmacovigilance Awareness and Training
• Implementation of Pharmacovigilance Agreements
• Collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases
• Submission of single cases to local Health Agencies (HA) and Ethics Committees (as required)
• Local Market Safety Data Quality
• Note: Distributor Agreement driven

Degree RequirementsUniversity degree (preferably health or life science) or nursing qualificationExperience Requirements

• ≥ 5 years in the Pharmaceutical Industry, usually with at least 3-5 years’ experience working in Pharmacovigilance or in a closely aligned field in the respective country(ies)
• Line management experience

Key Competency Requirements

• Strong leadership and Coordination 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. Positively contributes to the shaping of patient safety within the local market through interactions with the HA and relevant professional associations.
• Communicates with clarity and consistency to achieve alignment of stakeholder activities regarding safety risk related requirements internally (local/regional/HQ) and externally (HAs, BPs).
• Strong understanding of GxP and expert knowledge of local and global regulations
• Has a 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.

Travel RequiredMinimal travel required in this position. Trips could include travel to BMS sites, Health Authorities and to attend professional meetings and seminars.Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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.