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PV Safety Officer

Salary undisclosed

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IntePros is hiring a PV Safety Officer for our premier client! In this role, the contractor will work under the supervision of the US Local Safety Officer (US LSO) and provide back-up support when the LSO is out of the office. The US Deputy Safety Officer will be responsible for ensuring compliance with relevant pharmacovigilance (PV) regulations and adhering to Global Safety & Pharmacovigilance (GSPV) policies. This role is critical in maintaining safety standards and ensuring regulatory compliance within the organization’s safety operations.

Responsibilities
  • Liaises with multiple people within the US Commercial and/or Global Commercial teams who are to inform the Safety Officer about any new ODCS programs.
  • Responsible for maintenance and of the global ODCS entries of the programs involving USA via HaloPV to ensure compliance with the PSMF (Pharmacovigilance System Master File) obligations.
  • Reviews and comments on questionnaires/surveys/discussion guides for any potential questions that would elicit safety information (i.e. adverse events) which will be used in an ODCS program.
  • Provides insights for process improvement and management of HaloPV and handling procedural documents.

Pharmacovigilance Agreements
  • Supports the implementation of Pharmacovigilance Agreements (PVAs) in close cooperation with the responsible Global PV Agreements & Alliance (GPAA) and relevant local functions (such as US Commercial).
  • Reviews and provides input/comments to the PVAs in close cooperation with the GPAA.
  • Negotiates the terms of the PVA with the 3rd Party Service Providers. If needed, brings Legal into the PVA negotiations with the Service Providers.
  • Notifies GPAA with confirmation & reason to terminate a PVA.

Training Of 3rd Party Service Providers
  • Defines third-party PV training requirements in his/her territory and ensure that this training is completed by the third parties in a timely manner.

Inspection/Audit Readiness
  • Assists the US LSO in maintaining the Inspection Contact List and the Roles & Responsibility List.
  • Manages findings assigned to US LSO/DSO.
  • Assists 3rd Party Service Provider(s) with audit responses when requested.

Minimum Required Qualifications
  • Bachelor’s degree (e.g. in the biological, nursing, healthcare or pharmaceutical sciences, quality or equivalent
  • 3+ years in the pharma industry, and knowledge in pharmacovigilance
  • Knowledge of US FDA regulations pertaining to Pharmacovigilance
  • Familiarity with international standards and regulatory requirements/regulations related to Pharmacovigilance and Good Clinical Practices
  • High level of computer literacy (e.g. Microsoft Office, SharePoint, training systems, document management systems, CAPA System)
  • Ability to establish and maintain good working relationships with internal and external stakeholders
  • Good verbal and written communication skills in English
  • Ability to work independently and as a team player, working in a cross functional environment
  • Ability to manage, resolve or escalate issues as appropriate
  • Self-motivated, able to prioritize, plan effectively
  • Demonstrates initiative with a proactive approach to work
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