Home
/
Comprehensive
/
Associate Director/Director, Drug Safety and Pharmacovigilance Scientist
Associate Director/Director, Drug Safety and Pharmacovigilance Scientist-April 2024
Cambridge
Apr 2, 2026
About Associate Director/Director, Drug Safety and Pharmacovigilance Scientist

  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 independently and in a team environment

  Proficient in standard computer software (Word, Excel, and Power point presentations)

  Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to details

  Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities

  Excellent written and verbal communication skills; able to interact across multiple functions

  Exhibits comprehension of industry practices and regulations for drug development and pharmacovigilance

  Gene-therapy safety science experience a plus, but not required

  Benefits

  Benefits Summary:

  Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

  If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.

  Fostering Belonging. Fueling Innovation. Transforming Lives.

Comments
Welcome to zdrecruit comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
SIMILAR JOBS
CDL Truck Driver Van OTR Fleet
In our over the road Van Fleet, you’ll haul largely no-touch freight across 48 states and Canada. As you see the nation, you’ll also see many different shippers and locations. You'll get our new Dyna
Staff Nurse - PACU - Mount Sinai Morningside - Full Time - 10 am - 8 pm
Responsible for the care activities and goal achievements of assigned patients by assessing, diagnosing, planning and intervening in actual or potential health problems and evaluating patient's respo
Licensed Master Social Worker 2 (McPike Addiction Treatment Center)
Agency Addiction Services and Supports, Office of Title Licensed Master Social Worker 2 (McPike Addiction Treatment Center) Occupational Category Health Care, Human/Social Services Salary Grade 20 Ba
Software Engineer (Product)
Summary: Meta Platforms, Inc. (Meta), formerly known as Facebook Inc., builds technologies that help people connect, find communities, and grow businesses. When Facebook launched in 2004, it changed
Account Executive - Boost Mobile (West Virginia)
Company Summary DISH, an EchoStar Company, has been reimagining the future of connectivity for more than 40 years. Our business reach spans satellite television service, live-streaming and on-demand
Welder (1st Shift)
75 South Hwy 83 McCook Nebraska 69001-8569 Why Valmont We’re Here to Move the World Forward. Valmont impacts millions of people around the world every day, yet they might not realize the many ways. O
Lead Merchandiser
Overview Come join the largest beer distributor in the United States and be a part of our Performance Promise where we live out our company’s purpose of connecting customers, consumers and brands eve
Delivery Driver
Have you ever thought about driving for one of those ride sharing companies? But, on second thought, you really don't want to make idle chit chat with a random stranger in your car. And, maybe a bett
RETAIL MERCHANDISING ASSISTANT NF2
Summary Marine Corps Community Services (MCCS) is looking for the best and brightest to join our Team! MCCS is a comprehensive program that supports and enhances the quality of life for Marines, thei
WDI Project Coordination Intern, Fall 2024 (Glendale)
About the Role & Program Walt Disney Imagineering is the creative force that imagines, designs and brings to life all Disney theme parks, resorts, attractions and cruise ships worldwide. Working
Copyright 2023-2026 - www.zdrecruit.com All Rights Reserved