Job Title: Director, Pharmacovigilance Quality Management
Reports to: Executive Director, Pharmacovigilance Operations and Quality Management
Cutting-edge headquartered in Cambridge, Massachusetts, is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates.
This position will oversee Pharmacovigilance (PV) quality management activities globally for all investigational and marketed products. This position requires a strategic leader with strong systems-thinking and problem-solving skills. The incumbent will join the PV department reporting directly to the Executive Director and Head of Pharmacovigilance Operations and Quality Management.
Primary Responsibilities include:
- Oversee the PV quality management program
- Develop, implement, and maintain a PV self-inspection program including inspection readiness
- Represent PV in audits and inspections including direct interactions with auditors and inspectors
- Establish and monitor Key Performance Indicators and metrics. Prepare and communicate management reports and score cards
- Monitor PV compliance with applicable plans, standard operating procedures (SOPs), regulations and guidelines
- Oversee creation and maintenance of the Pharmacovigilance System Master File
- Review case management plans, data entry conventions, SOPs, Pharmacovigilance Agreements, Safety Data Exchange Agreements, etc.
- Direct the development, implementation, and management of a PV training program
- Oversee the PV CAPA and process deviation management process internally and with PV vendor
- Provide EU good pharmacovigilance practices (GVP)-based quality management consultation to PV Operations and Risk Management teams
- Collaborate with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal, etc. in establishing and improving PV processes
- Identify, analyze, and implement opportunities for continuously improving PV processes and systems
- Support the Head of Pharmacovigilance Operations and Quality Management with developing and implementing appropriate PV processes and systems
Desired Education and Skills:
- Master's degree in Biological Sciences, Nursing, or Healthcare Administration; PharmD or PhD.
- Minimum 8 - 10 years' experience in PV Quality Management with at least 5 years of EU GVP implementation experience
- Strong systems-thinking and problem-solving skills
- Solid oral and written communication skills
- Demonstrated ability to build relationships and influence across disciplines and all levels
- Introspective and demonstrated ability to deliver results
- Thorough knowledge and understanding of global regulations for safety and pharmacovigilance including FDA, EMA, and ICH guidelines
- Experience with MS Visio
- Experience with Argus
- Patients First, Action, Unconventional Thinking, Talent, and Integrity
- Global experience is preferred
- Occasional travel may be required