Director, Safety Scientist

Boston, NH - USA

Monthly Salary: $ 175000 - 263000

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

The Director SafetyScientist plays a leadership role within Global Patient 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.

You will be responsible for:

Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:

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 patient safety at regulatory inspections i.e. MHRA 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 GPS in global program teams and associated cross functional teams and/or projects
Proactively provide guidance and educational training to GPS therapeutic teams
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 GPS Medical Directors
Responsible for project managing and authoring of safety documents including PSUR PBER PADER RMP REMS CSRs and ad hoc requestsin collaboration safety physicians.
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 Safety Physicians in the development of risk management strategy and activities for assigned products

You will have:

Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD Nurse Practitioner or PhD with 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 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

We would prefer you have:

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

The annual base pay for this position ranges from $175000 to $263000. Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.

Date Posted

28-Jan-2026

Closing Date

09-Feb-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.

Required Experience:

Director

You will be responsible for:

Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:

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 patient safety at regulatory inspections i.e. MHRA 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 GPS in global program teams and associated cross functional teams and/or projects
Proactively provide guidance and educational training to GPS therapeutic teams
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 GPS Medical Directors
Responsible for project managing and authoring of safety documents including PSUR PBER PADER RMP REMS CSRs and ad hoc requestsin collaboration safety physicians.
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 Safety Physicians in the development of risk management strategy and activities for assigned products

You will have:

Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD Nurse Practitioner or PhD with 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 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

We would prefer you have: