The Director/Sr. Director, Pharmacovigilance (PV) Operations will design, implement and manage the company’s PV system and insure adherence to all global regulatory requirements and internal processes and procedures. The qualified candidate will have experience in and perform multiple activities related to the overall global PV operations strategy across Stoke’s portfolio including case management, database strategy, vendor oversight, compliance, inspection readiness, budget, contract management, and trainings. The Sr. Director of PV Operations reports to the Chief Medical Officer.
This PV role is all about ensuring patient safety and working collaboratively together and cross-functionally to bring safe and effective medicines to our patients. This opportunity will allow you to drive the PV function at Stoke. It is an exciting time to work at Stoke as we expand our pipeline of RNA medicines and grow the company into a global organization.
- Provides strategic planning, oversight, and management of Stoke PV Operations activities.
- Provides vendor oversight and management for all outsourced PV activities, including establishing and monitoring key quality and compliance metrics.
- Provides expert guidance and leadership both internally and externally based on in-depth knowledge of development and safety requirements, per ICH; US and international regulations and guidelines; and EU Good Pharmacovigilance Practice (GVP).
- Designs and builds a PV system and internal safety database to support the department needs, including specific workflows and reporting/querying functionalities and is fully compliant with the applicable worldwide Health Authority PV regulations.
- Provides oversight of systems and MedDRA updates in collaboration with the relevant vendor(s).
- Develops and implements an inspection readiness program with the contribution of non-PV stakeholders.
- Responsible for compliant and quality execution of all operational activities related to case management and related activities.
- Oversees timely submissions of expedited reports to the FDA & other health authorities.
- Identifies deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level.
- Establishes a system for prevention and correction of deviations to compliance with internal and external stakeholders, in collaboration with the Quality Assurance department.
- Oversees the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate trials and products.
- Contributes to and implements department SOPs and work instructions related to the PV activities.
- Effectively collaborates with key stakeholders at all levels in the organization.
- Leads Internal Safety Review Committee meetings
- Participates in departmental and cross functional risk assessment, technology development, and process improvement initiatives.
- Represents PV as a leader on project teams, other departments, and committees.
- Hires additional PV team members to build a top-notch PV organization for Stoke.
- Other duties as assigned by the manager.
Required Skills & Experience:
- Life Science Degree or Healthcare Professional (PharmD, PhD, MS, BS, RN, or RPh).
- A minimum of 10 years of experience in PV Operations in the biopharmaceutical industry, with at least 5 years of leadership and managerial experience in overseeing global/regional PV operations.
- Experience in rare diseases is preferred. Neurology trial experience is desirable.
- Prior experience in ICSR case processing, aggregate safety reporting, PV quality management systems, and PV compliance (including major PV inspections).
- Expert knowledge of global PV regulatory guidelines and legislation requirements, e.g., US Code of Federal (CFR) regulations, European Union (EU), Guideline on GVP and ICH Guidelines.
- Experience and extensive working knowledge of MedDRA and proprietary safety databases.
- Significant experience working with CROs, vendors, and relationship management.
- Strong managerial skills across countries and ability to partner closely and effectively cross-functionally.
- Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes.
- Ability to combine PV expertise with exceptional leadership (strategic thinking, people, and resource management).
This position is based in Cambridge, MA.
This position will require 10-15% travel.
Benefits & Compensation:
Stoke Therapeutics offers comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Primary Caregiver Leave; a 401K program with company match, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.