Global Patient Safety: Associate Director, Safety Science

Alexion Pharmaceuticals, Inc.; Barcelona; On-site; EUR 120,000 - 160,000; Full time

Job summary

Alexion seeks an Associate Director, Safety Scientist to lead safety activities across product portfolios, mentor junior scientists, and support regulatory filings. The role involves representing GPS in inspections, guiding risk management strategies, and driving safety analytics across therapeutic areas.

The position requires a strong background in drug safety, regulatory knowledge (US/EU), and excellent cross-functional collaboration within a global team based in Barcelona.

Qualifications

• Bachelor's degree in biologic/medical/clinical/nursing field.
• At least 5 years experience in drug safety and risk management.
• Knowledge of US and EU safety regulations pre- and post- marketing.
• Experience with Risk Management and Minimization programs.
• Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans.
• Experience with clinical development including risk/benefit analysis and safety assessment.
• Strong clinical, analytical, problem solving and scientific writing and communication skills.
• Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis.
• Expertise with Microsoft Word, PowerPoint, SharePoint and Excel.

Responsibilities

• Managing safety scientist activities across multiple product portfolios and/or indications.
• Organizing, training and/or supporting junior safety scientists and fellows.
• Supporting activities related to new drug applications and other regulatory filings.
• Representing global patient safety at regulatory inspections e.g., MHRA, FDA, EMA, etc.
• Leading gap analysis to ensure alignment with changes in global regulations.
• Strategizing and drafting of responses to regulatory inquiries on product safety issues inclusive of defining MedDRA search strategy.
• Presenting GPS in global program teams and associated cross functional teams and/or projects as needed.
• Proactively providing guidance and educational training to GPS therapeutic teams.
• Participating in ongoing safety data review and analysis for products in designated therapeutic areas.
• Performing Signal Surviellance activities for respective programs in collaboration with GPS Medical Directors
• Project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requestsin collaboration with GPS Medical Directors
• Authoring safety sections, in collaboration with team members, on regulatory responses, IBs/CCDS, protocols, ICFs, Data Monitoring Committee reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.
• Manage portfolio of products/projects related to risk management; assists GPS Medical Directors in the development of risk management strategy and activities for assigned products
• Contribute to on-going process enhancement for safety analytics and reporting, such as developing standard procedures and templates
• Assisting GDS Medical Directors to oversee risk minimization activities including tracking of activities as needed
• May be directed by the line function to support initiatives outside of their projects

Skills

Drug safety

Risk management

Regulatory knowledge

Clinical development

Scientific writing

Cross-functional collaboration

Education

Bachelor's degree in biologic/medical/clinical/nursing field

Advanced degree preferred

Tools

MedDRA coding

Microsoft Word

PowerPoint

SharePoint

Excel

Job description

Alexion seeks an Associate Director, Safety Scientist to lead safety activities across product portfolios, mentor junior scientists, and support regulatory filings. The role involves representing GPS in inspections, guiding risk management strategies, and driving safety analytics across therapeutic areas.

The position requires a strong background in drug safety, regulatory knowledge (US/EU), and excellent cross-functional collaboration within a global team based in Barcelona.