Associate Director, Safety Scientist, Global Patient Safety

The Associate Director, SafetyScientist 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 inspectionse.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 activitiesfor 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; assistsGPS 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:

• Bachelorsdegree in a biologic/medical/clinical/nursing field

• At least 5 years experiencein 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.

We would prefer for you to have:

• 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