Medical Director, Patient Safety Physician

AstraZeneca; Barcelona; Presencial; EUR 100.000 - 130.000; Jornada completa

Descripción de la vacante

A global biopharmaceutical company in Barcelona is seeking a Medical Director for Patient Safety. This role involves managing Clinical Safety strategy for drug projects, evaluating safety data, and ensuring compliance with regulatory requirements. The ideal candidate will have a medical degree and at least 2 years of clinically relevant experience in Drug Development or Patient Safety. This position promises a collaborative work environment with opportunities for career advancement.

Formación

• At least 2 years of clinical experience post-registration.
• Experience in Drug Development/Patient Safety, primarily in the industry.
• High level of medical competence with industry standards.

Responsabilidades

• Responsible for Clinical Safety strategy across drug projects.
• Contribute to safety evaluations and risk management.
• Participate in safety governance and review submissions.

Conocimientos

Medical competence

Understanding epidemiological data

Leadership in Patient Safety

Educación

Medical degree (MD, MBBS)

MSc/PhD in scientific discipline

Descripción del empleo

Overview

The Medical Director, Patient Safety Physician is responsible for the Clinical Safety strategy for assigned AstraZeneca-MedImmune drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level. They are responsible for the continued safety assessment, evaluation and risk management of AZ products or product groups in various stages of clinical development and/or the post-marketing setting. They ensure continuous evaluation of adverse events and other safety information to predict and manage the safety profile of compounds in clinical development and marketed products, driving updates to reference safety information and proactive risk management initiatives in accordance with global regulatory requirements. They provide consistent communication of safety topics across regulatory safety documents (eg PBRERs, PADERs and DSURs) for assigned products/programs. They proactively evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other sources to predict establish the safety profile of compounds in development, employing expert groups and methodologies such as Safety Knowledge Groups (SKGs), Safety Science, Informatics, modeling and simulation to manage patient risk. They work collaboratively with experts across AZ-MedImmune and with colleagues from all three Science Units as a leader/member of a Safety Management Team/MedImmune Safety Review Team or as a member of other cross-functional project teams, promoting high quality evaluation of safety data. They understand the role of the QPPV and contribute to the maintenance of the pharmacovigilance system and processes. They support key contacts with opinion leaders, as needed. The principal accountabilities/responsibilities are summarized below.

Safety Governance and Risk Management activities

• Working with the Safety Team, be responsible for the Clinical Safety strategy for assigned AstraZeneca-MedImmune drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level. Activities include, but are not limited to: definition of identified and potential risks with high level mitigation and minimisation; proposals for mitigation/minimisation measures; safety go/no-go criteria for the clinical programme; input to TPP/TPC; safety submission strategies; response to regulatory safety queries and definition of the risk component of the benefit/risk assessment.
• Reviews and endorses the core Patient Risk Management Plan (PRMP) / Core Patient Risk Log (CPRL).
• Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation activities in the core PRMP, MedImmune dRMP, CPRL and globally reviewed LRMPs.
• Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.
• Provides medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.
• Provides strategic clinical safety input into Clinical Development planning activities in accordance with PS Operating Model and Science Unit Service Level agreements.
• Provides strategic and medical input to project-specific safety requirements (PSSR). Reviews and provides technical input and approval for investigator brochures, protocols, informed consents, final study reports and external data monitoring committees as appropriate.
• Provides input on cross-functional ad-hoc teams addressing urgent and important safety issues.
• May present safety information at clinical investigator and commercial meetings.
• Facilitates the establishment of a Safety Management Team/MedImmune Safety Review Team as necessary.

Signal Detection, Evaluation and Labelling

Involved in all safety surveillance activities, which may include medical review of individual safety cases, signal detection, evaluation and SERM activities (or Medimmune equivalent) for all products in area or responsibility.

• Provides medical input to regulatory supporting documentation for labeling updates.
• Provides medical input into identification and utilization of appropriate data sources and database searches to retrieve relevant data for evaluation of signals.
• Collaborates with external provider representatives in routine signal management activities.
• Discusses results of data evaluation with the Surveillance Team and/or appropriate key stakeholders (e.g., Patient Safety VP TA, QPPV/Deputy QPPV).
• Provides medical input to deliver accurate and fit-for-purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
• Provides strategic input into responses to regulatory requests for local label deviations from the company core safety documentation.
• In consultation with the PS scientist and Clinical representatives, prepares the Developmental Core Safety Information (DCSI) for assigned development products.

Regulatory Reports and Submissions

• Provides medical input and review of periodic reports (eg PBRERs, PSURs, DSURs) and renewal documentation submitted to regulatory agencies.
• Provides the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc) for new products, formulations or indications.

Other Activities

• Contributes to and/or reviews the PS component of Safety Agreements.
• Advises on the preparation of licensing agreements in therapeutic area of responsibility. Participates in AZ internal meetings with project focus.
• Participates in external regulatory and non-regulatory meetings including those with consultants and other companies such as licensing partners.
• May assist in due diligence activities.
• May provide support to AZ Legal for product liability litigation, as appropriate.
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
• Participates in, and may lead, a process improvement initiative team within PS.
• May contribute to advancement of methodology and process by generating new ideas and proposals for implementation.
• Raises concerns/issues to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated.
• May mentor and train junior members of the team in signal evaluation methodology, risk management and preparation of safety reports and other documents.
• Collaborates effectively in cross-functional and cross-cultural project teams and environments, and works with external providers.

Requirements – Education and Experience

Essential

• Medical degree (eg MD, MBBS)
• At least 2 years of clinical experience post-registration
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• At least 2 years of Drug Development/Patient Safety experience (the majority in industry in Patient Safety) with clear evidence of delivery

NB: It is not mandatory to meet the minimum requirements for length of experience or to have completed the UK Higher Medical Training in Pharmaceutical Medicine; these details are indicative of the level of knowledge, expertise and recognition required of an individual in this job.

Desirable

• Physicians will generally be expected to have completed Higher Medical Training in Pharmaceutical Medicine
• MSc/PhD in scientific discipline
• Able to work across TAs and Functions
• Experience of supervising Patient Safety colleagues
• A demonstrated ability to understand epidemiological data

Date Posted 08-Sept-2025

Closing Date 19-Oct-2025

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.