Associate Director, Safety Scientist

Boston, NH - USA

Monthly Salary: $ 126000 - 190000

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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 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 Surveillance 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 requestsin 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

You must 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 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

Nice 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
Knowledge of Power BI and other visualization tools

The annual base pay ranges from $126000 to $190000. 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

15-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