Job Description

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.

Senior Specialist, Global Patient Safety, India Asia Frontier

Role Profile

Ability to manage high-level aspects of patient safety activities and processes at the country level in collaboration with internal and external stakeholders to ensure that local and global PV requirements are adhered to across the AstraZeneca portfolio. Specialized in one or more processes within the PS safety team and provides oversight and expertise to the PS function. Ability to manage PS systems, databases, activities, and projects at the country level using patient safety knowledge and personal skills to run day-to-day PS work efficiently in compliance with local regulatory regulations and AstraZeneca requirements. Ability to manage audits, and local inspections, and liaise cross-functionally to meet PS requirements. Leadership skills and advanced PS knowledge are crucial for this role. Has the functional knowledge to deliver high standards, with increasing freedom to act without direct supervision. The job holder is expected to manage risk and develop reporting tools, and analysis processes to identify improvements. Deliver a centrally managed provision of services such as documents, systems management and solve complex problems within the patient safety area and participate in certain projects. The Role holders is considered an expert in their field, capable of providing technical guidance and will be expected to contribute to certain projects at a local level.

Accountabilities & Responsibilities

The Senior Specialist, Global Patient Safety contributes to the core components of the local pharmacovigilance system, by ensuring AZ has in place an effective pharmacovigilance system that complies with the local PV requirements.

The Core responsibilities may include:

Maintains in-depth knowledge of the local health authority regulations and updates regional lead & local teams with any new changes in legislation/guidance for discussion and escalation to relevant stakeholders in global Patient Safety as required. Maintain local procedural documents related to patient safety activities are up to date. Ensure 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 up-to-date knowledge of the marketed status of products in the local country and reference documents (such as Product Information/ core data sheet) in addition to maintaining up-to-date knowledge related to global patient safety procedures, guidance, and working instructions. Keep the awareness of any conditions or obligations and other commitments relating to safety or the safe use of the products. Support the creation, implementation, and maintenance of local risk management plans and risk minimization activities to support regulatory submissions in collaboration with cross-functional teams. Support full and prompt response to any patient safety query from the local regulatory authority related to patient safety function. Facilitate the necessary quality, including correctness and completeness, of PV data submitted to the local regulatory authority. Fully trained on different global PS systems (Argus, JASPER, Orbit, My time portal, VQV, Nominated Signatory Portal, Cover, ERV, Veeva CRM, and ECMS). Support local safety management agreements and clinical study protocols to fulfill AstraZeneca and local regulatory safety reporting requirements. Support AstraZeneca's external patient safety service provider to meet AstraZeneca and local regulatory pharmacovigilance requirements. Ensure cross-function collaboration through sharing patient safety knowledge with the local MC teams (e.g., Marketing, Sales, Regulatory Affairs, Medical Affairs) Ensure elements of Good Pharmacovigilance Practice are implemented at the local level. Conduct activities and interactions consistent with AstraZeneca's values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to the role. Managing Patient safety activities related to the processing and handling of Individual Case Safety Reports (ICSRs), and follow-up cases, received from clinical and post-marketed sources for AstraZeneca products in addition to conducting Monthly quality control processes. Ensure timely submission of ICSR, follow-up cases, and other safety documents (PBRERs, DSURs, Signals, SUSARs, RMPs, DHPCs, etc) to local health authorities. Annual update and testing of local Business Continuity Process (BCP) Support delivery of PS training to local staff and locally engaged vendors including annual refresher training. Manage Health Authority interactions and queries, such as for ICSR-related products, related safety concerns, and educational materials associated with the Risk Management Plan (RMP) Ensures corrective and preventative actions are taken in the event of local non-compliance. Ensure local standard operating procedures are in place and up to date for being ready for any patient safety audit and inspection. 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. Support review of medical and scientific literature to identify possible Adverse events in accordance with AstraZeneca and local regulatory pharmacovigilance requirements. Implement the elements of Good Pharmacovigilance Practice (GVP) at the country level. Manage external vendors that deliver Patient safety services. Management of the PV aspects relating to Organised Data Collection Programmes, Digital and Social Media activities, and other arrangements with external parties (such as Externally Sponsored Research (ESR), health authorities' partnerships, or other collaborations). Support patient safety projects at local & global levels. Act as a mentor to support newly appointed patient safety staff. Establish strong relationships and effective cross-function collaboration with regulatory, marketing, medical, and other internal and external stakeholders' functions to deliver patient safety requirements for business and regulatory needs. Complete all required patient safety training and adhere to internal processes and external regulations. Support management of local safety agreements and update Pharmacovigilance Agreement Listings (PAL) manage the reconciliation process related to ODCP, MI, PQC, and MSL insights to ensure the accuracy of pharmacovigilance data that is transferred & received. Update and submit the annual patient safety checklist. Ensure an after-hours process is in place, to ensure a customer can report an AE and respond to regulatory authority questions. Supports filing and archiving practices of patient safety documents. Ensure local processes, procedures, and systems are in place for reporting, processing, and translation of AEs from spontaneous and solicited sources. Ensure up-to-date organization charts, job descriptions, training records, and curriculum vitae are available. Manage patient safety compliance data monthly. Support audit & inspection process & respond to all related queries and manage the identified gaps as per GVP.

Global remit Guidance :

Own Country- Yes


Other Countries (Bangladesh, Brunei, Cambodia, Maldives, Myanmar, Nepal, Sri Lanka and all those within Asia Pacific & Southern Africa Global Patient Safety region, as needed)- Yes


Remit which covers all AstraZeneca countries- No

Education, Qualifications, Skills, and Experience:

Essential

Pharmacovigilance Knowledge Excellence Good Pharmacovigilance Practice Knowledge of health authority's regulations Cross Function Collaboration Data Analysis Effective Thinking & Problem solving Vendor Management Patient Safety systems management. Excellent attention to detail Excellent written and verbal communication skills

Desirable

Extensive Pharmacovigilance Knowledge Problem-solving, Influencing, and Conflict Resolution skills. Medical knowledge in AZ Therapeutic Areas Medical Marketing experience Change management skills Extensive Knowledge of health authority's regulations Cross Function Collaboration Leadership skills & act as a role model for the local PS team. Project management & proven record on above-market PS projects. Audit & Inspection experience

Key Relationships to Reach Solutions

Internal (to AZ or team)

Medical Information Medical Affairs Clinical Operations Regulatory Affairs Commercial Services including Digital, Procurement, and Business Development Corporate Communications Quality Assurance Management Sales and Marketing Information Services Legal & Privacy Global Regulatory Affairs and Patient Safety (GRAPSQA)

External (to AZ)

External Service Providers License Partners Healthcare professionals Other local and global stakeholders

Why AstraZeneca?

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.