Patient Safety Manager

Contenido de trabajo

The Patient Safety Manager is an appropriately qualified person for pharmacovigilance who is responsible for the local pharmacovigilance system, thus ensuring AZ have in place an effective pharmacovigilance system that complies with the prevailing regulatory requirements governing the conduct of pharmacovigilance.

Core responsibilities may include:

• Acting as the Pharmacovigilance Contact person, with regards to the requirements of the local Pharmacovigilance regulatory framework, which may include management of Individual Case Safety Report (ICSR) related queries, AZ product related safety concerns, or ownership of local activities related to the Risk Management Plan (RMP)

Acting as GVP Quality Lead, responsible for:

• Ensuring the GVP area is run in accordance with external regulations.
• Ensuring appropriate levels of resource to complete GVP activities appropriately
• Providing/ coordinating training and coaching in the GVP area for the Country QMS
• Identifying/ agreeing areas of compliance risk and follow-up of any issues
• Ensuring GVP self-assessments are completed
• Monitoring KPIs in the GVP area and proposing remedial and improvement actions
• Establishing improvement priorities
• Monitoring internal/external factors such as emerging regulation or shifts in regulatory enforcement
• Identifying trends and communicating identified risks
• Establishing and maintaining business continuity plans in the GVP area
• Management of all activities pertaining to the processing and handling of ICSRs, including adverse event reporting from clinical and post-marketed sources for AstraZeneca products
• Contribution to effective operational implementation of the Quality Management System appropriate to the GvP discipline, including: procedural document management, implementation of AE/PV training requirements across internal personnel and third party suppliers, managing quality incident reporting, and audit & inspection readiness
• Management of PV aspects relating to Organised Data Collection Programmes, Digital and Social Media activities, and other arrangements with external parties (such as Licence Partners (LP), Externally Sponsored Research (ESR), ODCP providers, partnerships or other collaborations etc)
• Provide Patient Safety expertise and guidance within the local Marketing company (e.g., Marketing, Sales, Regulatory Affairs, Medical Affairs) related to issue management for key products, risk management, formulating action plan/implementation, information gathering/extracting data, monitoring results of actions plans, and provide safety data expertise
• Leading or delivering on ad-hoc Global local country projects
  

Additionally, the PSM should:

• Ensure conduct of PV and submission of all PV-related documents is in accordance with the local requirements and Good Pharmacovigilance Practice (GVP)
• Establish strong relationships and effective collaboration between regulatory, marketing, clinical and other internal and external stakeholders functions to deliver patient safety requirements for business and regulatory needs
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to the role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
• Adherence to internal processes and external regulations including but not limited to clinical trials, promotional activity and pharmacovigilance activities to meet internal SOP and local regulations.
  

Marketing Company Patient Safety Manager responsibilities:

• Maintains an in depth knowledge of the local health authority, the regulations, expectations and regulatory authority contacts and ensures that upcoming changes in legislation/guidance are notified to their regional lead for discussion and escalation to relevant stakeholders in global Patient Safety as required
• Possesses working knowledge of applicable procedural documents
• Ensures that all local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF)
• Maintains oversight of all safety related processes, issues and brand activities within their country, including product risk management plans and associated activities.
• Maintains current knowledge of the marketed status of products in the local country and reference documents (such as Product Information/Datasheet)
• Awareness of any conditions or obligations and other commitments relating to safety or the safe use of the products.
• Plan, deliver and implement local risk management plans and risk minimization activities to support regulatory submissions in collaboration with cross-functional teams
• Ensure a full and prompt response to any request from the local regulatory authority for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product.
• Manages collection, processing and reporting of clinical and post-marketed adverse events from all sources
• Ensure internal and external stakeholder compliance with AstraZeneca requirements and global and local regulatory requirements, regarding adverse event reporting. Ensures corrective and preventative actions are taken in the event of local non-compliance.
• Ensures that when transfer of pharmacovigilance data occurs within an organisation or between organisations, the mechanism should be such that there is confidence that all notifications are received and that a confirmation and/or reconciliation process should be undertaken
• Ensures that an after-hours process is in place, to ensure a customer can report an AE, to respond to regulatory authority questions, to facilitate local health authority unscheduled inspections
• Ensures that filing and archiving practices follow the relevant AstraZeneca policy and that there is no destruction of safety-related documentation without prior reference to local Patient Safety
• Ensures that local processes, procedures and systems are in place for recording, processing, multiplying up and translation of AEs from spontaneous and solicited sources, AEs from local non-interventional studies and SAEs from local interventional clinical studies
• Ensures that local regulatory requirements are defined with respect to reporting ICSRs to local Health Authorities, local ethics committees and investigators (including when the clinical distribution hub is used) and ensures that these reports are tracked (tracking conducted by clinical hub when used), so that details of when a report was issued and to whom, are available
• Ensure the necessary quality, including correctness and completeness, of PV data submitted to the local regulatory authority
• Ensures that local processes are in place with respect to submission and tracking of periodic safety reports to local Health Authorities, investigators and ethics committees
• Is responsible for assessment of all non-serious AEs from spontaneous sources and the upgrade of relevant events to serious in accordance with the AstraZeneca Always Serious List & Designated Medical Events (DME) List
• Ensure local medical and scientific literature is reviewed to identify possible case reports in accordance with AstraZeneca and local regulatory pharmacovigilance requirements.
• Is trained in the use of the global tracking tool, JASPER, unless the tool is not available in the Country
• Ensures AEs are followed-up with health care professionals regarding cases (e.g., cases with legal, media or other issues)
• Ensures a local Business Continuity Process (BCP) for Patient Safety is in place
• Ensures that the relevant GSP is notified of potential safety signals and issues (including those posted on the local health authority website), and any unsolicited reports of unexpected benefit occurring with Approved Products are forwarded to the DES and the GSP/CPL
• Ensures that the local legal team are informed of threatened, possible or actual legal action
• Provide AE/PV training of local staff and locally engaged vendors. Develop and implement adverse event reporting including refresher training programs and materials in safety processes and procedures using the most effective adult learning principles for AstraZeneca personnel and external stakeholders to meet compliance targets.
• Deliver and manage local safety agreements and monitor compliance of safety data exchange with License Partners.
• Ensure delivery and management of safety agreements in and monitor compliance of safety data exchange with License Partners.
• Ensures that safety is being addressed in an ESRs study protocol.
• Manage AstraZeneca’s external patient safety service provider so that resources are applied in the most efficient way to fulfill AstraZeneca and local regulatory pharmacovigilance requirements
• Ensure up-to-date organisation charts, job descriptions, training records and curriculum vitae are available
• Ensures that appropriate cover is in place so that all activities continue to be performed within the required timeframes when the PSM is out of the office, on holiday, unexpected leave etc.
  

Essential

Education, Qualifications, Skills and Experience

• Degree Qualified – Pharmacy/ Medical/ Science
• Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry
• Extensive experience in relationship and stakeholder management
• Extensive knowledge of the current pharmacovigilance and regulatory developments
• Leadership skills, including proven leadership of project teams experience
• Demonstrated ability to set and manage priorities, resource goals and project initiatives
• Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships
• Experience in working cross-functionally
• Excellent attention to detail
• Excellent written and verbal communication skills
  

Desirable

• Advanced scientific degree
• Understanding of multiple aspects within Medical Affairs, Regulatory and Clinical Research
• Experience in planning, developing and implementing of Risk Management Plans
• Understanding of organised data collection programs and digital listening activities
• Experience of working with third party suppliers