Position summary
The senior safety scientist plays a leadership role within global drug safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the gds medical directors and cross-functional team members within the global regulatory framework
Job duties & responsibilities
Proven skill set for strategic leadership in a cross functional matrix
Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications
Co-lead activities related to new drug applications and other regulatory filings
Represent global drug safety at regulatory inspections i.eMhra, fda, ema, etc.
Lead analysis to identify and address changes in global regulations including updates to sop and process documentation
Leading activities to identify and address process gaps
Responsible for vendor management and training including budgets
Responsible for overall project distribution across therapeutic area
As needed represent gds in global program teams and associated cross functional teams and/or projects
Proactively provide guidance and educational training to gds therapeutic teams
The following activities to be completed with minimal oversight:
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 requests in collaboration safety physicians.
Authors and lead development of high quality 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 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
Strategizing and drafting of responses to regulatory inquiries on product safety issues inclusive of defining meddra search strategy
Contribute to on-going process enhancement for safety analytics and reporting, such as developing standard procedures and templates
Assist in review of individual case safety report (icsr) and analysis of similar events (aose) as necessary
Essential qualifications
Advanced degree in a biologic/medical/clinical/nursing field: pharmacist/pharmd, nurse practitioner or phd
At least 7 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 regulatory inspections i.eMhra, fda, ema, etc.
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 aptitude
Strong 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 clinical and safety databases
Experience in meddra coding and search strategies
Expertise with microsoft word, powerpoint, sharepoint and excel
Preferred qualifications
Rare disease pv expertise
Device/combo drug pv expertise
Registry experience
Posted on: friday, april 16, 2021
