Associate Director, Safety Scientist, Global Patient Safety

Location: Barcelona, Spain (on-site) 3 days working from the office.

The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework 

You will be responsible for: 

• 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 requests in 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 

You will need to have: 

• Bachelors degree in a biologic/medical/clinical/nursing field 

• At least 5 years experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry 

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