Medical Director/ Senior Patient Safety Physician

Drive patient safety at the forefront of global drug development!

At

AstraZeneca

, we’re dedicated to being a

Great Place to Work

. Here, you’re empowered to push the boundaries of science, unleash your entrepreneurial spirit, and make a meaningful difference to medicine, patients, and society. We foster an inclusive culture built on diversity, collaboration, and a commitment to lifelong learning, growth, and development.

Join

AstraZeneca

in

Gothenburg, Sweden

as a

Medical Director / Senior Patient Safety Physician

and play a pivotal role in shaping the safety strategy behind innovative medicines that can transform patients’ lives.

This is a high-impact leadership role for an experienced physician with deep expertise in

drug development

,

pharmacovigilance

, and

benefit-risk evaluation

. You will lead the

clinical safety strategy

for assigned AstraZeneca drug projects and products across all stages of development and, where relevant, in the post-marketing setting.

What’s in it for you?

You’ll work with key internal and external stakeholders, provide scientific leadership, and influence safety strategies that matter to patients around the world. The role offers broad exposure across

Research & Development

, with insight into how strategic direction is shaped within the clinical organisation and how critical decisions are made throughout the drug development lifecycle.

Working closely with cross-functional teams in

Clinical Development

, you will bring complex issues into clinical context and support informed, science-based decisions. It is also an excellent opportunity to continue growing your expertise in

drug development

,

science

, and

leadership

within a global, innovation-driven environment.

What you’ll do

You will lead the clinical safety strategy for assigned products and programs, representing both the

patient

and

Health Authority

perspective. You will provide senior medical expertise on the safety profile of products and disease areas, ensuring robust and proactive safety assessment throughout development and post-marketing.

Your responsibilities will include:

Leading clinical safety strategy and governance

for assigned projects and products, including implementation and communication at project team and governance level

Driving safety assessment, evaluation, and risk management

for AstraZeneca products or product groups in clinical development and/or the post-marketing setting

Reviewing adverse events and broader safety information

to help predict, characterise, and manage the safety profile of compounds and marketed products

Identifying updates to reference safety information

and driving proactive

risk management initiatives

in line with global regulatory requirements

Defining identified and potential risks

, proposing mitigation and minimisation measures, and contributing to safety go/no-go criteria, submission strategies, and benefit-risk assessments

Providing medical input into core safety documents

, including

PBRERs, PSURs, PADERs, DSURs

, renewal documentation, and other regulatory safety reports

Ensuring consistent safety messaging

across regulatory documents and contributing to responses to regulatory authority questions and labelling updates

Contributing to signal detection, signal evaluation, and surveillance activities

, including medical review of individual safety cases where appropriate

Providing medical input into Development Core Safety Information (DCSI)

and other product safety documentation

Leading patient safety contributions to global regulatory submissions

, including

NDA, BLA, and MAA

submissions for new products, formulations, or indications

Supporting clinical development planning

through strategic safety input into project-specific safety requirements, investigator brochures, protocols, informed consent documents, final study reports, and data monitoring committee materials as appropriate

Collaborating with experts across AstraZeneca

, including colleagues in Patient Safety, Clinical Development, Regulatory Affairs, pre-clinical safety, safety science, and safety informatics

Contributing to urgent safety issue management

, governance discussions, inspection and audit readiness, process improvement initiatives, and mentoring junior colleagues where relevant