Sr. Manager, PV Standards, Training & Compliance

Company: System One
Location: Stamford
Posted on: January 12, 2021

Job Description:

Title: Sr. Manager, PV Standards, Training & ComplianceLocation: Stamford, CT (remote available)Duration: ContractSchedule: Full Time M-FTarget Start Date: ASAP!ResponsibilitiesThe Senior Manager, PV Standards, Training & Compliance is a business area expert supporting the Executive Director and Head of Safety Operations, Standards and Compliance in establishing procedures and processes to ensure the overall compliance of the company-wide pharmacovigilance system with PV obligations both as Marketing Authorization Holder and Sponsor of clinical trials. * This is achieved by developing and delivering PV specific training for personnel and key vendors; developing and maintaining systems to oversee and track compliance with pharmacovigilance regulatory requirements, including 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 PV system is compliant with governing regulations and adequately described in Quality Management System documents.* Perform regular gap analysis of the pharmacovigilance system to ensure ongoing compliance with regulatory pharmacovigilance requirements globally. * Prepare proposals for the development of new PV specific procedures or IT systems, or for changes in existing ones as needed. * Where gaps in the quality management system exist or updates are needed, ensure continued compliance with regulatory pharmacovigilance requirements globally. * In cooperation with Quality Department also author new pharmacovigilance procedures or updates thereof, ensure their timely release, related training requirements and their implementation. * Ensure oversight of the applied PV 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 and its functioning and for monitoring ongoing compliance with all applicable regulatory pharmacovigilance requirements globally. Develop additional KPIs where needed to ensure proper overview of the system's performance. * Support the preparation for and management of PV related audits (internal and of key vendors and business partners) and Authority inspections. Participate in such audits as auditor as needed and provide support to pharmacovigilance inspections; participate as interviewee in such inspections as needed. * Provide input in annual PV Audit Plan and ensure ad-hoc updates are made should these become needed. * Receive and review reports on internal and external PV specific and non-PV specific audits and inspections and identify areas needing corrective and/or preventive actions. Ensure adequate root cause analysis is available and well documented to cover pharmacovigilance aspects. * Maintain the audit trail of CAPA plans with PV relevance and create living overview of their status of executional progression and completion. Escalate overdue CAPAs or CAPAs at risk to the Executive Director and Head of Safety Operations. * Advise on role specific training matrices for personnel from a pharmacovigilance perspective. * Deliver PV training to Personnel and, on request also to service providers (vendors) and business partners. Ensure proof is available of adequate and continued fulfilment of PV training requirements for all Personnel.* Provide input into PV requirements and clauses necessary to be included in contracts with service providers (vendors) for PV specific and other services (for instance vendors to whom management is potentially outsourced or who are supporting Market Research, social media screening projects or other), as well as in contracts with business partners and investigators in investigator sponsored clinical trials that are supported by company. * Ensure that a living overview of such contracts is available to PV and--monitor compliance of the third parties with the clauses in the contracts, propose corrective or preventive actions where needed to restore compliance or assure continued compliance. * 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 PV system. Requirements * 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) guidelinesJoule, 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.

Keywords: System One, Stamford , Sr. Manager, PV Standards, Training & Compliance, Executive , Stamford, Connecticut