Associate Director, Safety Scientist, Global Patient Safety
- Barcelona
- Permanente
- Tiempo completo
- 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
- Representing 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
- Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors
- 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 GPS 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
- 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- 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
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: 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.
- Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD
- Expertise with clinical and safety databases
- Experience in MedDRA coding and search strategies
- Excellent, independent judgment based on knowledge and expertise
- Strong personal time-management and project-management skills
- Mastery of Microsoft Word, PowerPoint and Excel