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$187k–$281k/yr
Full-time
postgraduate degree
Retirement programs, Paid time off, Vacation, Holiday, Leaves, Health coverage
Posted 10d ago
Apply by Sep 17
~40 hrs/week
Responsibilities
The Director, Safety Scientist provides strategic oversight and scientific leadership for the evaluation and management of safety risks across the portfolio. They are responsible for leading safety surveillance, authoring regulatory safety documents, and developing a team of safety scientists to ensure high-quality, evidence-based safety outputs.
Requirements
Candidates must possess an advanced degree in a biologic, medical, clinical, or nursing field and at least 7 years of experience in drug safety or pharmacovigilance. Strong expertise in global pharmacovigilance regulations, risk management, and cross-functional leadership is required.
Full job description
The Director, Safety Scientist serves as a key leader within Global Patient Safety, providing strategic oversight and scientific leadership for the evaluation and management of safety risks across the portfolio through:
Leading the scientific evaluation and management of safety risks across assigned programs, with accountability for high-quality, evidence-based outputs
Driving proactive, data-informed safety strategies in close partnership with GPS Medical Directors and cross-functional stakeholders
Ensuring robust, timely, and aligned benefit–risk assessments throughout the product lifecycle
Overseeing delivery of safety science activities, ensuring consistency, quality, and adherence to timelines
Shaping safety strategy and recommendations that inform governance discussions and key decision-making forums
Leading, coaching, and developing a team of Safety Scientists, fostering scientific rigor, accountability, and continuous improvement
Promoting consistency in scientific approach and execution across programs and team members
Collaborating effectively across clinical, regulatory, and other functions to ensure alignment of safety priorities and actions
Strengthening the overall safety capability of the organization through leadership, innovation, and knowledge sharing
Responsibilities for this role include, but are not limited to:
Clinical Safety Leadership
Lead and develop a team of safety scientists, drive performance, growth and scientific excellence
Ensure appropriate resourcing and talent quality across assigned portfolio, including recruitment and team planning
Lead initiatives for process improvement and cross-departmental process consistency
Lead implementation of new processes, systems, and ways of working to enhance efficiency and scalability
Provide oversight of vendors, including management, onboarding and training
Represent GPS in clinical study teams and cross functional meetings
Promote and enable cross-functional, proactive and solutions-orientated team actions and behaviors
Lead workstreams and/or projects with high impact to the business
Participate as a core member of GPS leadership team
Portfolio Management Expertise
Set safety team goals aligned to TA and product strategy
Collaborate with medical directors to lead project-specific safety strategy for assets within the assigned portfolio
Responsible for the overall scientific and clinical safety content for the assigned portfolio
Responsible for the implementation and the high-quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned portfolio
Provides strategic safety knowledge and support to the safety scientists through initiation, execution, and completion of the clinical programs for the assigned portfolio
Responsible for the quality of key safety deliverables (e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs))
Responsible for ensuring compliance and adherence to PV regulations for the assigned portfolio
Safety Expert
Authoring or reviewing safety sections of clinical documents including but not limited to the clinical study protocol, informed consent form, Investigator’s Brochure, statistical analysis plan, clinical study report, and data monitoring committee documents
Coordinating, preparing, and completing high-quality aggregate safety reports (e.g., PSUR, PBRER, PADER) for submission to regulatory agencies globally
Leading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis results
Leading the authoring and project management of health authority queries
Maintaining accountability for the authoring, review and finalization (i.e., endorsement, sign-off) of risk management plans and contributing to REMS documents
Assisting GPS Medical Directors in the development of risk management strategy
Supporting activities related to new drug applications and other regulatory filings including authoring, reviewing and providing input to eCTD modules (2.5 and 2.7.4), core product information (i.e., CCDS), and local labels
Representing global patient safety at regulatory inspections (e.g., MHRA, FDA, EMA)
Messaging and External Impact
Maintains a high degree of understanding and awareness of new and emerging clinical safety developments globally
Maintains strong networks globally; works with international colleagues and with external alliance partners on safety initiatives and regulatory issues
You will have:
Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD
At least 7+ years’ experience in drug safety/pharmacovigilance within the pharmaceutical industry or biotech
Subject matter expertise in global pharmacovigilance regulations, maintaining a strong, up-to-date working knowledge of evolving global requirements
Experience with:
Preparing aggregate safety reports and conducting signal surveillance
clinical development including risk/benefit analysis and safety assessment
Risk management and minimization programs
Proven skill set for strategic leadership in a cross functional matrix
Strong analytical, problem solving, and scientific writing skills
Demonstrated learning agility and ability to work independently
Sound, independent judgement based on knowledge and expertise
Advanced project leadership with strong organizational and prioritization skills
Strong personal time-management and project-management skills
Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
Understanding of downstream regulatory, patient, business, and reputational impact of PV actions
We would prefer you have:
Expertise with clinical and safety databases
Experience in MedDRA coding and search strategies
Experience with data visualization tools (e.g., Power BI, Spotfire)
Experience with various roles in drug safety (e.g., case processing, operations)
Mastery of Microsoft Word, PowerPoint and Excel
The annual base pay for this position ranges from $187K to $281K. Our positions offer eligibility for various incentives—an 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
02-Sep-2026
Closing Date
16-Sep-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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.
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