On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a
Senior Manager, Patient Safety, Distributor Markets
|Research and Development / Global Regulatory, Safety and Biometrics /
Worldwide Patient Safety/International Patient Safety
Functional Area Description
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 / Objective
- 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
- 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
- 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
University degree (preferably health or life science) or nursing qualification
- ≥ 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.
Minimal travel required in this position. Trips could include travel to BMS sites, Health Authorities and to attend professional meetings and seminars.