Specialist, Global Patient Safety, Southern Africa

Do you have expertise in, and a passion for science? Does working in Oncology, Biopharma and Rare Diseases, whilst creating value for our customers and patients sound rewarding? If so, AstraZeneca might be the one for you!

ABOUT ASTRAZENECA

AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the worlds most serious disease. But were more than one of the worlds leading pharmaceutical companies. At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. Our strategic priorities reflect how we are working to deliver our strategy and achieve our Purpose.As a workforce, we are the catalyst for our values: we are entrepreneurial; we do the right thing; we play to win; we put patients first and we follow the science. As a company we appreciate and take great pride in each team member where every person is brought together through shared values, that underpins a shared purpose. Theres no better place to feel inspired and energised.At AstraZeneca, were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Join the fastest-growing pharmaceutical in our markets, set up to fuel further growth. Be part of our shared ambition and pride: our strong heritage, our turnaround story, and early investment and commitment in International markets. Theres no better place to feel inspired and energized.

ABOUT THE TEAM

You will join a high performing locally based team, who are part of the Global Patient Safety organistion. This team combine technical expertise with commercial acumen, to ensure we meet the Licence to Operate function of pharmacovigilance. Agility and problem-solving is second nature, with an enterprise mindset you will proactively take ownership of activities to deliver on our accountability and moves out of comfort zones to achieve the best results.

What youll do

You will contribute 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. You will be a critical team member, directly contributing to the maintenance of the Licence to Operate Pharmacovigilance function, via the following:• Contribute to the teams overall remit which aims to optimize operations, reduce risk, and increase compliance, as well as generate robust data analytics within the patient safety function.• Supports activities in collaboration with internal and external stakeholders to ensure that local and global PS requirements are adhered to across the Company products portfolio.• Works as part of the local PS team and the Marketing Company (MC) team, using functional knowledge to provide technical and operational support to different PS activities, processes, local databases, and other PS systems.• Support the overall local Patient Safety organization in achieving compliance with company and regulatory requirements.• Support activities of PS function and may work under the guidance of more senior experts and is expected to deliver routine activities independently.• Works independently to sort out problems of moderate scope and complexity, ensure effective delivery to the required standards, manage reporting tools, and use PS software to support processes at the local level.• Provides technical assistance in the management of Patient Safety processes and systems.

Role Profile

Ability to contribute to the teams overall remit which aims to optimize operations, reduce risk, and increase compliance, as well as generate robust data analytics within the patient safety function.

Supports activities in collaboration with internal and external stakeholders to ensure that local and global PS requirements are adhered to across the Company products portfolio.

Works as part of the local PS team and the Marketing Company (MC) team, using functional knowledge to provide technical and operational support to different PS activities, processes, local databases, and other PS systems.

Supports the overall local Patient Safety organization in achieving compliance with company and regulatory requirements.

Supports activities of PS function and may work under the guidance of more senior experts and is expected to deliver routine activities independently.

Works independently to sort out problems of moderate scope and complexity, ensure effective delivery to the required standards, manage reporting tools, and use PS software to support processes at the local level.

Provides technical assistance in the management of Patient Safety processes and systems.

Accountabilities & Responsibilities

The 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:

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.

Establish strong relationships and effective collaboration between regulatory, marketing, medical, and other internal and external stakeholders, to deliver patient safety requirements for business and regulatory needs.

Actively contribute to maintaining the core components of Good Pharmacovigilance Practice, via contribution to all safety-related processes and brand activities within countries of remit, and being audit and inspection ready

Maintain current and in depth knowledge of

relevant country health authority regulations;

global and local procedural documents and guidances;

marketed status of products in the local country and reference documents (e.g. Core Data Sheet);

conditions or obligations and other commitments relating to safety or the safe use of the products.

Complete all required patient safety trainings, adhere to internal processes and external regulations, obtain access to relevant systems, such as Safety Database, Regulatory systems, Human resources systems, Quality Management Systems, and other global or local systems commercial databases as appropriate.

Effective operational and 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.

Support projects at local & global levels.

Support external service providers to meet the company and local regulatory PV requirements

Support provision of the following activities:

local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF);

capture and escalate as appropriate changes in legislation/guidance;

creation, implementation, and 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 query from the local regulatory authority related to patient safety function;

Health Authority interactions, such as for ICSR-related queries, product-related safety concerns, and activities associated with Risk Management Plan (RMP)

local safety management agreements and clinical study protocols to fulfill The Company and local regulatory safety reporting requirements

maintenance of local procedural documents related to patient safety activities

delivery of PS training to local staff and locally engaged vendors including annual refresher training.

processing and handling of Individual Case Safety Reports (ICSRs), including adverse events from clinical and post-marketed sources (including Literature)

local processes, procedures, and systems are in place for reporting, collection, translation, processing, and reporting of clinical and post-marketed adverse events from all sources, and implementation of corrective and preventative actions are taken in the event of local non-compliance

Quality (including correctness and completeness) and timely submission of PV data submitted to the local regulatory authority (for example ICSR and follow-up information, SUSARs, PBRERs, DSURs, Signals, RMPs, DHPCs, etc)

reconciliations, ensuring the accuracy of pharmacovigilance data that is transferred & received

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)

management of local safety agreements and update relevant Pharmacovigilance Agreement Listings systems

maintenance and testing of local Business Continuity Process (BCP)

after-hours process, ensuring a customer can report an AE and respond to regulatory authority questions

filing and archiving practices of patient safety documents

retention of up-to-date organization charts, job descriptions, training records, and curriculum vitae

If this sounds appealing, please read on to understand the experience and skills were looking for…

ESSENTIAL SKILLS AND EXPERIENCE

Pharmacy, or other equivalent science qualification

1-3 years work experience (Community/hospital pharmacy, or similar role in the Pharmaceutical industry or Clinical trials all accepted_

Excellent written and verbal communication skills

Cross functional collaborative approach

Influencing, and Conflict Resolution skills

Lateral thinking ability

Problem solving skills

Excellent attention to detail

Medical knowledge in company Therapeutic Areas

Desirable:

Pharmacovigilance knowledge

Knowledge of health authoritys regulations

Vendor management experience

French language skills (written and verbal)

Project management

Audit & Inspection experience

Why AstraZeneca?

AstraZeneca South Africa, Kenya, and Nigeria have been awarded the TopEmployer certification for 2026! This is the sixth consecutive certification for South Africa and Kenya, and the third consecutive year for Nigeria, showcasing our consistent dedication to a better world of work. This distinction is a confirmation of our commitment and ability to sustain people, partnerships, and employee engagement and foster an innovative workplace environment.

We have also obtained 2025-2026 BestPlacesToWork certification for the third consecutive year through our distribution partners in Ivory Coast and Senegal. South Africa has also obtained first time certification for BestPlacesToWork and BestPlacesToWorkForWomen! This achievement aligns seamlessly with our broader mission to make a positive impact on health and wellness, and is a reflection of a work environment that is not only enriching and supportive, but also emphatically prioritises diversity, inclusion, and the well-being of all our employees.

At AstraZeneca, were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres 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. Were on an exciting journey to pioneer the future of healthcare. Join the fastest-growing pharmaceutical in our markets, set up to fuel further growth. Be part of our shared ambition and pride: our strong heritage, our turnaround story, and early investment and commitment in International markets. Theres no better place to feel inspired and energized.

SO, WHATS NEXT?

Are you already imagining yourself joining our team? Good, because we cant wait to hear from you!

Click the link to apply no later than 06/02/2026 and well be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Close Date: 06 February 2026

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.