Patient Safety Specialist

Contenido de trabajo

The Patient Safety Specialist is an appropriately qualified person for pharmacovigilance who contributes to the core components of the local pharmacovigilance system, thus ensuring AZ have in place an effective pharmacovigilance system that complies with the legal pharmacovigilance requirements.

Core responsibilities may include:

• Supporting activities pertaining to the processing and handling of Individual Case Safety Reports (ICSRs), including adverse event reporting from clinical and post-marketed sources for AstraZeneca products
• Supporting Health Authority interactions, such as for ICSR related queries, product related safety concerns, and activities associated with Risk Management Plans (RMP)
• 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
• Contributing to the 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
• Participating in ad-hoc Global or local country projects
• Maintain 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
• Working knowledge of applicable procedural documents
• Inclusion of local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF)
• Maintain oversight of all safety related processes, issues and brand activities within their country, including product risk management plans and associated activities.
• Maintain 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.
• Support creation, implementations, maintenance of local risk management plans and risk minimization activities to support regulatory submissions in collaboration with cross-functional teams
• 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.
• Collection, processing and reporting of clinical and post-marketed adverse events from all sources
• Support 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.
• Support 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
• Facilitate 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
• Suport 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
• Suports 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
• Facilitate 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
• Facilitate the necessary quality, including correctness and completeness, of PV data submitted to the local regulatory authority
• Facilitate local processes are in place with respect to submission and tracking of periodic safety reports to local Health Authorities, investigators and ethics committees
• Support 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
• Facilitate local medical and scientific literature review 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
• Ensure AEs are followed-up with health care professionals regarding cases (e.g., cases with legal, media or other issues)
• Facilitate a local Business Continuity Process (BCP) for Patient Safety is in place
• Facilitate 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
• Facilitate 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.
• Support delivery and management of local safety agreements and monitor compliance of safety data exchange with License Partners.
• Support local safety management agreements and clinical study protocols fulfill AstraZeneca and local regulatory safety reporting requirements.
• Facilitate safety being addressed in an ESRs study protocol.
• Support 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
• Ensure appropriate cover is in place so that all activities continue to be performed within the required timeframes when out of the office, on holiday, unexpected leave etc.
  

Additionally, the PSS 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 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.
  

Essential

Education, Qualifications, Skills and Experience

• Degree Qualified – Pharmacy/ Medical/ Science
• Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry
• Thorough knowledge of the current pharmacovigilance and regulatory developments
• Experience in working cross-functionally
• 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
• 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