Sr. Manager, Pharmacovigilance Standards, Training & Compliance
Category: Scientific & Clinical
Title: Sr. Manager Pharmacovigilance Standards, Training & Compliance
Location: Greenwich CT (remote available)
Schedule: Full Time M-F
Target Start Date: ASAP!
- The Senior Manager, Pharmacovigilance Standards, Training & Compliance is a business area expert supporting the Executive Director and Head of Safety Operations, Standards and Compliance
- Responsible for establishing procedures and processes to ensure the overall compliance of the company-wide pharmacovigilance system (drug safety) PV obligations for both as Marketing Authorization Holder and Sponsor of clinical trials.
- Develop and deliver pharmacovigilance PV specific training for personnel and key vendors
- Develop and maintain systems to oversee and track compliance with pharmacovigilance regulatory requirements
- Oversight of system performance, assurance that adequate CAPA plans are installed where needed and are timely completed
- Provide support to the development of written procedures to ensure that the pharmacovigilance PV system is compliant with governing regulations and adequately described in Quality Management System documents.
- Perform regular gap analysis of the pharmacovigilance (drug safety) system.
- Prepare proposals for the development of new
Pharmacovigilance (PV) specific procedures or IT systems.
- Ensure oversight of the applied pharmacovigilance procedures and standards
- Ensure CAPAs are put in place where needed and are executed.
- Build systems (procedural and electronic) to facilitate oversight by the Executive Director and Head of Safety Operations of the PV system.
- Develop additional KPIs where needed to ensure proper overview of the system’s performance.
- Maintain the audit trail of CAPA plans with
Pharmacovigilance (PV) relevance
- Advise on role specific training matrices
- Deliver Pharmacovigilance training to Personnel
- Provide input into Pharmacovigilance (PV) requirements and clauses necessary to be included in contracts with service providers (vendors)
- Support the Executive Director and Head of Safety Operations in the monitoring of changes and new developments in the regulatory pharmacovigilance requirements globally.
- Provide support in signaling, assessing and implementing the potential impact of such changes and new developments on Pharmacovigilance (PV) system.
- Bachelor’s degree in healthcare or life sciences
- An advanced degree such as PharmD, RN or BSN is preferred
- 5+ years of experience in pharmacovigilance quality and compliance monitoring
- 3-4 years of direct experience in Pharmacovigilance Compliance, global setting preferred
- Possesses strong knowledge of Food and Drug Administration (FDA), European Union (EU), and International Conference on Harmonization (ICH) guidelines
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.