Patient Safety Specialist

2 weeks ago


Petaling Jaya, Malaysia AstraZeneca Full time

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

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.

**Core Accountabilities**
- 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,


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