Medical Director, Global Patient Safety

Alexion; Barcelona; On-site; EUR 140,000 - 200,000; Full time

Job summary

Alexion seeks a Medical Director, Global Patient Safety to lead safety risk management for assigned products and development programs, ensuring safe and effective use for patients and clinicians. You will guide safety content, contribute to regulatory documents, and represent GPS in governance forums, delivering analyses to support risk/benefit decisions.

Requires an MD or equivalent in life sciences with strong Patient Safety and Drug Development experience.

Qualifications

• MD or equivalent degree in life sciences/pharmacy/nursing.
• Experience in Patient Safety and/or Clinical/Drug Development.
• Ability to manage multiple complex tasks and timelines.

Responsibilities

• Lead risk management evaluation and resolution for products and projects.
• Own safety content for assigned assets and indications.
• Deliver Safety & Strategy Management Team and Safety Surveillance Team outcomes.
• Define safety content aligned to GPT strategy and safety messaging.
• Contribute to study design and safety-related documentation.
• Chair or direct Safety Management Team with risk/benefit focus.
• Represent GPS in internal committees and external meetings.
• Detect, validate and manage safety signals pre- and post-approval.
• Evaluate safety data for regulatory documents and labeling updates.
• Provide safety analyses to support regulatory decisions.
• Serve as safety knowledge source for Product Team.

Skills

Problem solving

Multi-tasking

Verbal communication

Written communication

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Education

MD or life sciences/pharmacy/nursing degree

Tools

Microsoft Word

PowerPoint

Excel

Job description

This is what you will do:

The Medical Director, GlobalPatientSafety (GPS)is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's products by patients and healthcare providers.The Medical Director willbe responsible forsafety activities for investigational products and/or marketed, includingidentification and evaluation of safety signals and risk management to drive decision-making on risk/benefit evaluation.The Medical DirectorGPSwill be supervised byGlobalSafety Program Lead.

You willbe responsible for:

Leadingrisk management evaluation and resolution for assigned products and projects.Accountability/responsiblefor the following:

• Responsiblefor the overall scientific and clinical safety content for the assigned asset(s) or indications.

• Responsiblefor the implementation and thehigh qualitydelivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s).

• Responsible for overall safety content for the product orindication(s) alignedtoGPTstrategy. Sets safety team goals aligned to TA and product strategy.

• For the assigned asset(s),responsiblefor safety TPP, Safety Go/No Go criteria, safety communication/messagingand the guidelines for toxicity management of the asset

• Responsiblefor safety contribution to study designs and study concept delivery within their assigned program

• Chairingand/or directingthe Safety Management Team for the assigned project(s) or product(s) ensuring a safety and risk/benefit driven agenda frominceptionto closure

• RepresentingAlexionGPSat internal strategic and/or advisory/governance committees,other project/product team(s) orsubteam(s) as a key cross functional member and subject matter expert,and/oract as an external technical resource at DSMB or Regulatory Authority meetings

• Detecting,validating,and managingpre-and/or post-approval safety signals through to resolution

• Evaluatingaggregate safety data and providingcontributions to core regulatory documentsi.e.Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes asrequired

• Identifying,initiating,and managingto completion, necessary updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as necessary

• Overseeing safety sections of documents and safety interactions with Regulatory authorities. This mayinclude:authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs

• Deliversanalysesof clinical safety data in a balanced and statistically robust manner, to drive interpretations and develop novel proposals.

• Serves as a source of scientific and clinical safety knowledge for the Product Team, in theanalysesand interpretation of scientific and clinical safety data.

• Thisjob description is not exhaustive and may include otherotherjob-related duties as assigned.

You willneed to have:

• MD or equivalent degreeoralife sciences/pharmacy/nursing degree,anddemonstratedPatient Safety and/or Clinical/ Drug Development experience

• Sound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions tohighly complexproblems

• The ability to manage multiple overlapping complex tasks to conclusion, sometimes to tight timelines, for several projects and sub-projects, including oversight of others working on those projects

• Knowledge and understanding of GPS deliverables,standardsand processes

• Knowledge and understanding of US and EU safety regulations pre- and post- marketing

• The duties of this role aregenerally conductedin an office environment.As is typical of an office-based role, employees must be able, with or withoutan accommodationto:use a computer; engage in communications via phone, video, and electronic messaging;engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We wouldpreferfor you to have:

• 2-3 years relevant safety and risk management experience in the pharmaceutical, biotech or CRO industry

• Rare, Ultra-Rare or Orphan Disease Area experience

• Strong verbal and written communicationskillsincluding making recommended courses of action to management and/or senior leaders thatimpactthe discipline,departmentor line, and influences their decisions

• Excellent, independent judgment based on knowledge andexpertise

• Strong personal time-management and project-management skills

• Mastery of Microsoft Word,PowerPointand Excel

Date Posted

27-Aug-2026

Closing Date

30-Oct-2026

Alexion is proud to be an Equal Employment Opportunity and Affi We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation, please contact [e-mail]. Alexion participates in E-Verify.