Senior Director, Drug Safety Operations

At Editas, our mission is to champion belonging, inclusivity, diversity, and equity, cultivating a culture where every individual feels valued and included. This commitment fuels our drive to excel in scientific innovation, allowing us to harness the power of gene editing to develop groundbreaking and life-changing therapies for people living with serious diseases with the greatest unmet needs.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

The Senior Director of Drug Safety & Pharmacovigilance (DSPV) Operations will have direct oversight of vendor(s) conducting PV operational activities and play a key role in the overall safety operational strategy and safety reporting for all products at Editas Medicine. This position is responsible for supporting the operational aspects of the pharmacovigilance system and adherence to all regulatory requirements and internal processes and procedures. The qualified candidate must be able to collaborate with multiple stakeholders internally and with the vendor(s) and will have experience in performing multiple activities related to overall safety operations function, including adverse event case management, database strategy, SOP creation and maintenance, vendor oversight, compliance, inspection readiness, contracts, and training.

Requirements

Key Responsibilities:

As the Senior Director, you will be responsible for:

• Drives strategic planning, implementation, and management of DSPV Operations activities
• Responsible for managing internal and external staff allocated to operational PV activities, interacting with project teams across different resources
• Provides expert guidance and leadership based on in-depth knowledge of safety requirements, per ICH, local and global regulations and guidelines, and Good Pharmacovigilance Practice (GVP)
• Provide vendor oversight and management for all outsourced and/or insourced PV activities, ensuring aggregate safety reporting and adverse event information is processed according to company timelines and quality standard
• Ensures that the DSPV database supports the department’s needs, including specific workflows and reporting/querying functionalities. Provides oversight of systems and MedDRA updates in collaboration with the relevant PV vendor
• Oversee the set-up of any new safety projects, including the development of study-specific Safety Management Plans and set up of safety systems and database configurations to accommodate these trials and products
• Contributes to strategy and development of department SOPs and work instructions related to the DSPV activities
• Continues to develop, enhance, and implement a DSPV inspection readiness program with the contribution of other PV and non-PV stakeholders
• Support signal management activities, including signal investigations and drafting signaling reports
• Collaborate on aggregate safety reports including project management, data requests, data analysis, data interpretation, narrative writing, and quality checks
• Support SAE reconciliation activities on assigned clinical studies
• Contribute to development and maintenance of Safety Data Exchange Agreements (SDEAs) and DSPV agreements with partners, vendors, and other third parties
• Contribute to responses from Regulatory Authorities, particularly safety requests
• Effectively collaborates with key stakeholders at all levels in the organization. including Clinical Development, Clinical Operations, Biometrics, Medical Affairs, Regulatory Affairs, Medical Affairs, and Business Partners to develop compliant procedures in line with industry standards and best practices
• Represents DSPV on project teams and committees, as needed

Required Qualifications:

The ideal candidate will possess:

• Bachelors/Advanced degree preferably in life science, nursing, pharmacy, or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.)
• Minimum 10 years (12 years for Senior Director) of DSPV operations experience within the biotechnology or pharmaceutical industry, including 5 years in management position overseeing business process outsourcing vendors and relationships
• Experience with safety databases (ARGUS, ARISg, or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems
• Experience with the compilation, writing and reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, sub