We are recruiting, on behalf of our client, a Patient Safety Senior Manager.
You will join the International Patient Safety Group.
The 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.
Contractor 1 year
· Holds responsibility for oversight of all Patient Safety activities performed by the Distributor
· Plans, develops and communicates local WWPS strategy and expected operationalization 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 the Company 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
· 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
· 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.