Pharmacovigilance Safety Officer

4 weeks ago

King of Prussia, United States IntePros Full time

Contractor, under the supervision of the US Local Safety Officer (US LSO), is nominated as the US Deputy Safety Officer (US DSO), providing back-up to the US LSO when OOO, and is responsible for the specific tasks (described below) to ensure compliance with relevant Pharmacovigilance (PV) regulations and with Global Safety & Pharmacovigilance (GSPV) policies.


Specific Tasks.

Organized Data Collection System (ODCS):

  • 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.


Education.

Bachelor’s degree (e.g. in the biological, nursing, healthcare or pharmaceutical sciences, quality or equivalent


Experience.

3+ years in the pharma industry, and knowledge in pharmacovigilance



Competencies.

  • 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
  • Knowledge of US FDA regulations pertaining to Pharmacovigilance
  • Familiarity with international standards and regulatory requirements/regulations related to Pharmacovigilance and Good Clinical Practices
  • Self-motivated, able to prioritize, plan effectively
  • Demonstrates initiative with a proactive approach to work
  • High level of computer literacy (e.g. Microsoft Office, SharePoint, training systems, document management systems, CAPA System).

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