Associate Director Safety Scientist Global Drug Safety-11264

This is what you will do:

The Associate Director SafetyScientist plays a leadership role within Global Patient Safety to actively evaluate and manage risk in collaboration with the GPS Medical Director and crossfunctional team members within the global regulatory framework

You will be responsible for:

• Represent global drug safety at regulatory inspections i.e. MHRA FDA EMA etc.
• Lead gap analysis to ensure alignment with changes in global regulations
• Manage safety scientist activities across multiple product portfolios and/or indications
• Strategizing and drafting of responses to regulatory inquiries on product safety issues inclusive of defining MedDRA search strategy
• Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
• Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GDS Medical Directors
• Responsible for project managing and authoring of safety documents including PSUR PBER PADER RMP REMS CSRs and ad hoc requestsin collaboration with safety physicians.
• Authors highquality aggregate safety reports to meet regulatory and internal deadlines; ensures all safety regulatory documents are processed and submitted according to regulatory requirements
• Responsible for authoring safety section in collaboration with team members on regulatory responses IBs/CCDS protocol ICF review Data Monitoring Committees reports and requests and other documents and provide the necessary quality control to ensure alignment with core safety position.
• Manage a portfolio of products/projects related to risk management; assists GDS Medical Directors in the development of risk management strategy and activities for assigned products
• Assists GDS Medical Directors to oversee risk minimization activities including tracking of activities as needed
• Assists in the evaluation of risk minimization activity
• Assist with responses to regulatory inquiries related to risk management plans under the guidance of GDS Medical Directors.
• Supports activities related to new drug applications and other regulatory filings
• Contribute to ongoing process enhancement for safety analytics and reporting such as developing standard procedures and templates
• Assist in the review of Individual Case Safety Report (ICSR) and analysis of similar events (AOSE) as necessary
• Manage train and/or support junior safety scientists and fellows
• 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 preand postmarketing
• Experience with Risk Management and Minimization programs
• Experience preparing postmarketing safety regulatory documents including PSURs PBRERs and Risk Management Plans
• Experience with clinical development including risk/benefit analysis and safety assessment
• Strong analytical problemsolving 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

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