Director, Safety Scientist
Alexion
boston, ma
Compensation: 200.000 - 250.000
Overview
The Director, Safety Scientist 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.
Responsibilities
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 requests in 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
Qualifications
- 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
Preferred Qualifications
- 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 $175,000 to $263,000. 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
Closing Date
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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