AstraZeneca Opening for Senior Patient Safety Specialist Job Apply now

At AstraZeneca we are guided in our work by a strong set of values, and we’re resetting expectations of what a biopharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Job – Description

You will be responsible for patient safety matters covering data from clinical studies and the marketed use of AstraZeneca products, defined in the Global SOPs as the Marketing Company Patient Safety Associate. You will report to Patient Safety Manager in India Cluster

Key Responsibilities And Accountabilities

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.
Contribution to effective operational implementation of the Quality Management System appropriate to the GvP discipline, and/or 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.
all activities pertaining to the processing and handling of ICSRs, including adverse event reporting from clinical and post-marketed sources for AstraZeneca products,
management of PV aspects relating to Organised Data Collection Programs, Digital and Social Media activities, and other arrangements with external parties (such as License Partners (LP), Externally Sponsored Research (ESR), ODCP providers, partnerships, or other collaborations etc.)
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.
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)
Contributes 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 medical and scientific literature is reviewed to identify possible case reports in accordance with AstraZeneca and local regulatory pharmacovigilance requirements.
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 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 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 Requirements

Medical graduation/ M.Pharm / M.Sc/ PhD
3-6 years’ experience in handling Patient safety (Pharmacovigilance)
Conversant and relevant experience with Indian regulations specific to Pharmacovigilance
Function specific as well as overall pharmaceutical industry knowledge
Ability to build stakeholder relationships.
Strong negotiation and advisory skills
Analytical mindset and knowledge management
Collaborative working style
Ability to drive performance and act decisively.

Desirable Requirements

Knowledge of the NDCT-2019 and applicable Pharmacovigilance guidance in India
Knowledge of Pharmacovigilance activities in Asia Frontier countries (Bangladesh, Bhutan, Cambodia, Maldives, Myanmar, Nepal, and Sri Lanka.
People and organization development ability

IN OFFICE STATEMENT, EQUAL OPPORTUNITIES STATEMENT, CALL TO ACTION

Office Working Requirements – When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.