Sr. Manager, PV Standards, Training & Compliance
Company: System One
Location: Stamford
Posted on: January 12, 2021
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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
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