Title: PV Safety Officer (Pharmacovigilance Specialist)
Consult, 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.
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.
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
