Medical Director, Global Patient Safety

Barcelona - Spain

Monthly Salary: Not Disclosed

Posted on: 15 hours ago

Vacancies: 1 Vacancy

Job Summary

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 Alexions 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 committeesother project/product team(s) orsubteam(s) as a key cross functional member and subject matter expertand/oract as an external technical resource at DSMB or Regulatory Authority meetings

Detectingvalidatingand 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 as

Identifyinginitiatingand 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 will need to have:

MD or equivalent degreeoralife sciences/pharmacy/nursing degreeanddemonstratedPatient 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 deliverablesstandardsand 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 disciplinedepartmentor line and influences their decisions

Excellent independent judgment based on knowledge andexpertise

Strong personal time-management and project-management skills

Mastery of Microsoft WordPowerPointand Excel

Date Posted

05-Feb-2026

Closing Date

30-Mar-2026

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. 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 statuspregnancy (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 . Alexion participates in E-Verify.

Required Experience:

Director

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 Alexions products by patients and healthca...

This is what you will do:

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 committeesother project/product team(s) orsubteam(s) as a key cross functional member and subject matter expertand/oract as an external technical resource at DSMB or Regulatory Authority meetings

Detectingvalidatingand 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 as

Identifyinginitiatingand 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 will need to have:

MD or equivalent degreeoralife sciences/pharmacy/nursing degreeanddemonstratedPatient 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 deliverablesstandardsand 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 disciplinedepartmentor line and influences their decisions