Location: Barcelona, Spain
Job reference: R-208727
Date posted: 09/11/2024
This is what you will do:
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.
Leading gap analysis to ensure alignment with changes in global regulations.
Strategizing and drafting responses to regulatory inquiries on product safety issues, including 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 Surveillance activities for respective programs in collaboration with GPS Medical Directors.
Project managing and authoring 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 providing the necessary quality control to ensure alignment with core safety position.
Managing portfolio of products/projects related to risk management; assisting GPS Medical Directors in the development of risk management strategy and activities for assigned products.
Contributing to ongoing 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:
Bachelor's 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-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.
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