Latest Medical Jobs in AstraZeneca!
Join AstraZeneca in Bengaluru as a Patient Safety Cluster Lead for Asia Pacific and be at the forefront of ensuring the well-being of patients across the region. If you are an experienced professional with a passion for patient safety, this is your opportunity to make a significant impact. Lead a dynamic team, drive safety initiatives, and contribute to AstraZeneca’s commitment to improving healthcare worldwide. Your journey to elevate patient safety starts here!
Job Title: Patient Safety Cluster Lead
Company: AstraZeneca
Location: Bengaluru, Karnataka, India
Job Description: Latest Medical Jobs in AstraZeneca
The Patient Safety Manager is an appropriately qualified person for pharmacovigilance who is responsible for the local pharmacovigilance system, thus ensuring AZ has in place an effective pharmacovigilance system that complies with the prevailing regulatory requirements governing the conduct of pharmacovigilance.
Essential For The Role:
- 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 team 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 organizational relationships
- Experience in working cross-functionally
- Excellent attention to detail
- Excellent written and verbal communication skills
Responsibilities: Latest Medical Jobs in AstraZeneca
- Have oversight and line management responsibilities for safety activities in own country, and up to 5 additional countries in the Asia Region.
- 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, ownership of local Risk Management Plan-related activities
- Acting as GVP Quality Lead, responsible for:
- Ensuring the GVP area is run in accordance with external regulations.
- Ensuring appropriate levels of resources to complete GVP activities appropriately
- Providing/ coordinating training and coaching in the GVP area for the Country QMS
- Identifying/ agreeing to areas of compliance risk and following up on 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 regulations or shifts in regulatory enforcement
- Identifying trends and communicating identified risks
- Establishing and maintaining business continuity plans in the GVP area
- Establish strong relationships, provide Patient Safety expertise and guidance, and provide effective collaboration between local stakeholders within the Marketing company and externally
- 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
- Leading or delivering on ad-hoc global or local country projectsCore Accountabilities: Latest Medical Jobs in AstraZeneca
- Maintain an in-depth knowledge of the local health authority, the regulations, expectations, and regulatory authority contacts and ensure 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
- Ensure 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 the 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, delivered and implemented 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 the transfer of pharmacovigilance data occurs within an organization or between organizations, 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, 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 translating 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 the submission and tracking of periodic safety reports to local Health Authorities, investigators, and ethics committees
- Is responsible for the 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 benefits occurring with Approved Products are forwarded to the DES and the GSP/CPL
- Ensures that the local legal team is informed of threatened, possible or actual legal action
- Provide AE/PV training for 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 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 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 organization 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, on unexpected leave, etc.
