Associate Director/Director Drug Safety & Pharmacovigilance Operations

Fogpharma - Cambridge, MA

Full-time - Senior

Hybrid - Cambridge, MA

About the position

The Associate Director/Director of Drug Safety & Pharmacovigilance (DSPV) Operations at FogPharma is responsible for leading and overseeing the DSPV department, ensuring compliance with global regulatory requirements, and managing pharmacovigilance vendors. This role involves strategic planning, implementation of DSPV operations, and collaboration with various stakeholders to support the development and safety of FogPharma products.

Responsibilities

• Drive strategic planning, implementation, and management of DSPV Operations and Compliance activities
• Provide oversight and management of outsourced PV operational activities
• Develop and maintain PV related documentation (e.g., Safety Management Plans, reporting forms, etc)
• Represent DSPV on project teams and committees, as needed
• Oversee the set-up of new clinical trials/products within DSPV
• Review clinical documents and study plans as requested
• Contribute to the preparation of aggregate safety reports
• Support signal management activities
• Contribute to development and maintenance of Pharmacovigilance or Safety Data Exchange Agreements (PVAs/SDEAs) with partners or other third parties
• Support inspection readiness activities and participate in regulatory inspections
• Ensure overall compliance of the PV system in accordance with global regulatory requirements
• Review and monitor vendor quality and compliance of outsourced PV operational activities
• Develop, review and deliver PV related training
• Collaborate with key stakeholders at all levels of the organization and across multiple functions
• Provide 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)
• Oversee the resourcing, budget, and management of the PV vendor
• Maintenance of the DSPV mailbox and SharePoint

Requirements

• Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (RN, PharmD, NP, PhD, MPH, etc.)
• Eight + (8+) years working in DSPV Operations within the pharmaceutical or biotechnology industry
• In-depth knowledge of Good Clinical Practice (GCP); GVP; ICH guidelines; FDA, EMA, and other international regulations and guidelines; clinical trial conduct, and process and quality management
• Strong leadership and management skills, with a track record of building and developing high-performing teams
• Experience overseeing and managing PV vendors
• Previous experience with safety database programs (e.g., Argus, ARISg)
• Strong interpersonal and communication skills (both written and oral)
• Self-motivated and adaptable in a dynamic, nimble, start-up environment
• Detail-oriented, with good organizational, and time management proficiencies
• Ability to work on multiple projects simultaneously
• Demonstrated and creative problem solving skills
• Ability to establish priorities, excellent sense of urgency and a strong desire to collaborate
• Strong computer skills and experience using Microsoft Office applications
• Ability to work on-site or remotely and attend in-person meetings
• Ability to work cross culturally and with a variety of time zones