Pharmacovigilance Specialist

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