Global Alliances Consultant (Pharmacovigilance Specialist)

Compensation Range:

78-88

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IntePros is hiring a Pharmacovigilance Specialist (Global Alliances Consultant) for our client in King of Prussia, PA! This hybrid role supports the GCSP Global Pharmacovigilance Agreements and Alliances team (GPAA) in maintaining the global overview on all business relationships with Third Parties which require contracting of pharmacovigilance obligations/ responsibilities and in extending the current processes and systems to align efficiently with the client's standards.

Overviews the preparation and maintenance of Pharmacovigilance Agreements (PVAs) between the client and/or its affiliates, and partner companies (e.g., licensor or licensee), Distributors, 3rd Party Service Provider and Investigators/ Institutions according to client standards and international pharmacovigilance regulations. This includes close interaction with all client functions business units involved in PVA preparation and review process and tracking of timely completion.

Must have a minimum 3+ years pharmacovigilance experience and 2+ years PG agreements or SDA experience in drug safety.

Responsibilities:

• Responsible for maintenance of the operational aspects of the client's globally harmonized Pharmacovigilance Agreements (PVAs) process, covering products authorized, marketed, or supplied by client business units according to client standards / processes and international pharmacovigilance legislations.
• Provide ongoing support to the maintenance and improvement of the client's Contract Management System and PV Platform/ System allowing timely preparation, tracking, oversight, follow up, signature, and archiving of contracts of relevant PVA activities for business units. Review alignment to ensure the information available in the global overview of PV relevant business relationships is in a current status.
• Contribute to the electronic global PVA system and support GCSP functions in its utilization and maintenance. Assist in maintaining an enhanced global contract database and updates of PV Platform/ System addressing workflows for preparation and maintenance of contracts (i.e., PVAs) as well as achieving finally signed contracts and oversight of all types of business relationships where Pharmacovigilance obligations have to be covered by PVAs.
• Interact closely with local and global functions (e.g.: PVA Contact Persons (i.e.: LSO/ RSO)) to support the preparation and update of PVAs. Assist to provide guidance to cover specific pharmacovigilance requirements and obtain clarification of any PVA related issues and in association with the GCSP GPAA team.
• Contribute to the further development of the current global PVA System including quality standards, processes, communication, management of interfaces and PV Platform/ System in close liaison with the GCSP GPAA team.
  
  
  

Experience:

• Degree level minimum Bachelor of Science or equivalent, Pharmacy or Nursing.
• Pharmaceutical industry experience of at least 5 years in Pharmacovigilance, relevant clinical environment, or
  
  
  

other pharmaceutical sciences. At least 2 years PV Agreement/ SDEA experience required.

• Experience and good knowledge in the Pharmacovigilance (PV) relevant regulatory framework.
• Strong experience in major aspects of PV to evaluate possible safety issues that might arise from contractual
  
  
  

arrangements and to perform risk-based maintenance of PV-contracts.

• Experience in the handling of electronic systems for data management and in communication required in a global
  
  
  

organization.