Medical Director, Patient Safety Physician

Introduction to role:
Are you ready to lead the charge in ensuring patient safety? As the Medical Director, Patient Safety Physician at AstraZeneca, you'll be at the forefront of developing and implementing clinical safety strategies for our innovative drug projects and products. Your expertise will guide the continuous assessment and management of safety profiles, ensuring that our products meet the highest standards throughout their lifecycle. Dive into a role where your medical insights will shape the future of patient care, from clinical development to post-marketing.

Accountabilities:
Safety Governance and Risk Management activities
- Collaborate with the Safety Team to develop and communicate Clinical Safety strategies for AstraZeneca drug projects.
- Review and endorse core Patient Risk Management Plans and Logs.
- Provide medical expertise for safety specifications, pharmacovigilance plans, and risk minimization activities.
- Represent Patient Safety on cross-functional Clinical and Project Teams.
- Ensure risk-minimization strategies are appropriately implemented in relevant documents.
- Offer strategic clinical safety input into Clinical Development planning activities.
- Provide strategic and medical input to project-specific safety requirements.

Signal Detection, Evaluation and Labelling
- Engage in safety surveillance activities, including medical review of individual safety cases and signal detection.
- Contribute medical input to regulatory documentation for labelling updates.
- Collaborate with external providers in routine signal management activities.
- Discuss data evaluation results with Surveillance Team and key stakeholders.
- Deliver accurate safety evaluation documents in response to internal or regulatory requests.

Regulatory Reports and Submissions
- Provide medical input and review of periodic reports submitted to regulatory agencies.
- Contribute to global regulatory submissions for new products, formulations, or indications.

Essential Skills/Experience:
- Medical degree (MD, MBBS)
- Minimum of 3 years of clinical experience
- High level of medical expertise with industry standards
- At least 2 years of Drug Development/Patient Safety experience in industry

Desirable Skills/Experience:
- MSc/PhD in scientific discipline
- Ability to work across Therapy Areas and Functions
- Experience supervising Patient Safety colleagues
- Understanding of epidemiological data

At AstraZeneca, we are driven by a commitment to transform patient care through innovative science and technology. Our dynamic environment fosters collaboration and empowers individuals to make a meaningful impact. With a growing BioPharmaceuticals pipeline, we are dedicated to addressing the evolving needs of patients and healthcare professionals. Join us in shaping the future of medicine, where your ambition can thrive alongside a diverse team that values creativity and forward-thinking approaches.

Ready to make a difference? Apply now and be part of our journey to redefine patient safety!

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.