Associate Director/Director, Drug Safety and Pharmacovigilance Scientist
Editas Medicine, United States
Job Description
At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
The Drug Safety and Pharmacovigilance (DSPV) Scientist Associate Director/Director will provide critical DSPV quality and operational support for all Editas Medicine products throughout the life-cycle. The incumbent will support the medical component of DSPV activities including aggregate reports, signaling and risk management activities, individual case safety reports, and safety vendor oversight. This individual will collaborate closely with the safety physician and cross-functional partners to monitor, evaluate and actively manage safety risks in accordance with global regulatory frameworks.
Responsibilities:
- Provide DSPV support and representation for Editas Medicine’s clinical developmental programs in close collaboration with Clinical Development, Clinical Operations, Medical Affairs, Regulatory, Data Management and Biostatistics/Programming
- Establish successful working relationships with, and provide oversight to CROs and other vendors for day-to-day DSPV activities including but not limited to case processing and aggregate reports
- Carry out routine DSPV safety signal management activities including performing case series review and tabulated/line-listings data review for identifying and assessing safety signals and adequately documenting discussions, conclusions, and decisions
- Support activities in preparation of aggregate safety reports (e.g. DSURs, PBERs, etc.) including project management, safety data requests, providing contents to assigned section assimilating information from other groups, and performing data verification checks
- Review and provide DSPV input for development of protocols, IBs, SAPs, CSRs, and other relevant project/study documents
- Participate in clinical trial activities, including coding review, SAE reconciliation, etc.
- Provide DSPV input for regulatory submissions and regulatory responses, and collaborating with cross-functional areas as appropriate
- Participate in safety-led meetings, including the Safety Review Committee (SRC), Independent Data Monitoring Committee (IDMC) meetings, and other safety-related presentations
- Contribute to health authority and other safety related query responses
- Assist with writing/review and maintenance of Safety Monitoring Plans, Safety Data Exchange Agreements, DSPV Standard Operating Procedures, etc.
- Participate in inspection readiness activities and preparation as needed
- Participates in literature surveillance activities
- Actively involved in process improvement and compliance activities
- Participate in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations.
- Alert DSPV management for any identification/escalation of issues
- Other tasks and responsibilities as required
Requirements
Qualifications:
- Degree in Pharmacy, Nursing, Epidemiology, or equivalent healthcare degree with pharmaceutical industry background preferred; Applicants with more than 10 years of experience in Drug Safety and Pharmacovigilance may be considered
- Minimum 7 years (10 years for Director level) of pharmaceutical experience, preferably in Drug Safety and Pharmacovigilance
- Knowledge of GCPs, ICH guidelines, and FDA, EMA, and other international regulations
- Experience with safety databases (ARGUS, ARISg, or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems
- Experience and extensive working knowledge of MedDRA, WHO-DRUG, and safety databases
- Experience with clinical development including risk/benefit analysis and safety assessment
- Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information
- Experience with the compilation, writing and reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority, submission documents, and safety labels
- Strong relationship-building skills, with ability to interact effectively in a multifunctional, multicultural, growing organization; Able to work independent