The Director, Pharmacovigilance Quality and Compliance provides expertise and guidance in establishing and maintaining a pharmacovigilance quality system. The Director has a leadership role in the development, implementation and maintenance of the pharmacovigilance quality system encompassing policies, procedures, manuals, surveillance, and key performance metrics. Policies and procedures will be designed to promote pharmacovigilance compliance across Myovant companies and functional lines. The Director assists in overseeing the quality of work performed by contract service providers responsible for pharmacovigilance activities and works closely with Myovant Quality and Pharmacovigilance Operations to this regard.
The Director reports to the Senior Director, Pharmacovigilance Operations.
Essential Duties & Responsibilities:
- Provide a high level of expertise in establishing and maintaining quality systems for pharmacovigilance.
- Establish monitoring systems for key performance indicators and generate metrics for senior management.
- Ensure functional lines prepare and maintain processes to support a quality pharmacovigilance system.
- Work with Quality to document and compile quality review findings, ensure implementation of corrective actions and preventative actions, and verify positive resolution, as required.
- Collaborate with department senior staff, Quality, and key stakeholders as necessary to establish an inspection readiness process for pharmacovigilance and oversee ongoing readiness activities.
- Actively participate in the development, implementation and maintenance of department or company pharmacovigilance procedures, including pharmacovigilance quality system documentation and a pharmacovigilance quality manual.
- Participate in the review of Safety Management Plans (SMP), Pharmacovigilance Agreements (PVA), and other documents related to safety services with external parties.
- Monitor external party compliance with SMPs, PVAs and other relevant agreements.
- Work with Quality to establish a risk-based pharmacovigilance audit program and assist in conducting pharmacovigilance audits as necessary.
- Contribute to the maintenance of the pharmacovigilance system master file.
- Oversee the training requirements for the department and assist Quality in maintaining department training requirements and records.
- Maintain pharmacovigilance training materials for use in training applicable contract service providers on Myovant’s safety data reporting requirements.
- Identify gaps in the pharmacovigilance system and implement solutions.
- Assist with other department activities as needed.
Core Competencies, Knowledge and Skill Requirements:
- Experience writing procedures in the pharmaceutical industry
- Knowledge of current US and international pharmacovigilance regulations
- Proficient using computerized systems (PC-Windows and MS Office)
- Bachelor's required
- Minimum of 8 years relevant industry experience in a Quality organization; more than 2 years pharmacovigilance experience is preferred.
- Experience performing or hosting audits
- Project leadership/management skills