Associate Director, Safety Scientist
About The Position
The Associate Director, Safety Scientist provides strategic leadership and project management within Global Patient Safety to proactively evaluate and manage safety risks for assigned products throughout their lifecycle. The role works closely with GPS Medical Directors and cross-functional team members and follows global and local regulations, GxP practices, and company procedures. The position is based in Boston, Massachusetts, and reports to the Director, Safety Scientist, GPS. The role leads safety data review and analysis, safety surveillance, and preparation or review of clinical and regulatory safety documents. It oversees safety strategy and management for assigned assets, supports risk management and regulatory activities, represents Global Patient Safety in inspections and cross-functional forums, and mentors junior safety scientists and fellows. It also contributes to continuous improvement in safety analytics, reporting, and processes. Duties are generally conducted in an office environment. Employees must be able, with or without accommodation, to use a computer; communicate by phone, video, and electronic messaging; perform problem solving, analysis, and dialogue; collaborate with others; and remain generally available during standard business hours.
Requirements
- Bachelor’s degree in a biologic, medical, clinical, or nursing field.
- At least 5 years of pharmaceutical industry experience in drug safety or pharmacovigilance.
- Subject matter expertise in global pharmacovigilance regulations.
- Experience preparing aggregate safety reports and conducting signal surveillance.
- Experience with clinical development, including risk/benefit analysis and safety assessment.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Strong scientific writing skills.
- Demonstrated learning agility and ability to work independently.
- Ability to apply decision-making principles and contribute to key scientific and clinical discussions.
- Sound, independent judgment based on knowledge and expertise.
- Ability to interact effectively with colleagues of multiple disciplines and cultures, both within and outside the company, globally.
- Understanding of the downstream regulatory, patient, business, and reputational impact of pharmacovigilance actions.
- Ability, with or without accommodation, to use a computer; communicate by phone, video, and electronic messaging; engage in problem solving, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours.
Nice To Haves
- Advanced degree in a biologic, medical, clinical, or nursing field; examples include Pharmacist/PharmD, Nurse Practitioner, or PhD.
- Expertise with clinical and safety databases.
- Experience in MedDRA coding and search strategies.
- Strong personal time-management and project-management skills.
- Experience with data visualization tools such as Power BI or Spotfire.
- Advanced project leadership, with strong organizational and prioritization skills.
- Experience in various drug safety roles, such as case processing or operations.
- Mastery of Microsoft Word, PowerPoint, and Excel.
Responsibilities
- Lead safety data reviews and analyses for products in designated therapeutic areas.
- Author or review safety sections of clinical documents, including protocols, informed consent forms, Investigator’s Brochures, statistical analysis plans, clinical study reports, and data monitoring committee documents.
- Coordinate, prepare, and complete aggregate safety reports, such as PSURs, PBRERs, and PADERs, for global regulatory agency submissions.
- Oversee safety for assigned assets, including implementing and executing the Safety Strategy and Management Team (SSaMT) and Safety Surveillance Team (SST).
- Lead program- and study-level safety surveillance, including safety data analysis and communication, authoring internal safety review documents, presenting to cross-functional decision-making bodies, and documenting and tracking signal analysis results.
- Lead the authoring and project management of health authority queries.
- Account for authoring, reviewing, and finalizing risk management plans, including endorsement and sign-off, and contribute to REMS documents.
- Assist GPS Medical Directors in developing risk management strategy.
- Represent Global Patient Safety at regulatory inspections, such as MHRA, FDA, and EMA inspections.
- Mentor, train, and/or manage junior safety scientists and fellows.
- Support new drug applications and other regulatory filings by authoring, reviewing, and providing input to eCTD modules 2.5 and 2.7.4, core product information (CCDS), and local labels.
- Assist Global Safety Physicians in developing strategies for safety-related regulatory activities.
- Proactively manage safety documents by driving timely execution, engaging cross-functional stakeholders, and adhering to safety governance and regulatory timelines.
- Support continuous improvement in safety analytics and reporting by contributing to standardized procedures and templates.
- Represent Global Patient Safety as a subject matter expert in clinical study teams and cross-functional meetings.
- Contribute to process improvement initiatives and cross-departmental process consistency.
- Maintain current working knowledge of evolving global regulations.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
