Principal, Pharmacovigilance Agreements (PVA)

Job title : Principal, Pharmacovigilance Agreements (PVA)
Location : Cambridgeshire
Job type : Contract/Freelance
Salary : Negotiable
Contact name : Pauline Markina
Contact email : pauline.markina@secpharma.com

This role will work in the Pharmacovigilance Processes, Partnerships and Contracts (PV PP&C) area, negotiating optimal safety agreements and contracts for the client whilst establishing excellent collaborations and maintaining positive working relationships with third party partners.

Client: Large pharma
Location: Cambridgeshire or Cheshire (remote during COVID-19)
Duration: 12 months
Operating model: LTD or umbrella
Rate: Negotiable based on experience

Responsibilities:
- Negotiating optimal, compliant, Pharmacovigilance (PV) Agreements for the client whilst establishing excellent collaborations and maintaining positive working relationships with third party partners (i.e. Licensing Partners)
- Providing customers with expert advice, guidance and interpretation of matters pertaining to PV Agreements to demonstrate the value of Patient Safety as a key contributor to the client's internal and external business
- Collaborate with PS CoE, GPPS and Legal providing advice and support for commercial agreements ensuring that optimal and compliant PV obligations are included as required
- Collaborate with MC Safety Managers, providing advice and support for the creation and management of local PV Agreements
- Provide support to all LP audits as required and ensure remediation of findings
- Coordination and ownership of the lifecycle management of the Licensing Agreements process enabling business continuity and compliance

Essential requirements:
- A background in pharmacovigilance agreement management/negotiation
- Strong negotiation and cross-functional skills
- A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
- Experience in working cross-functionally and proven ability to work across cultures
- Leadership skills, including proven leadership of project teams experience
- Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues and thorough knowledge of the drug development process
- Strong collaboration, negotiation, conflict management and interpersonal skills
- Ability to influence whilst maintaining an independent and objective view

Desirable requirements:
- MSC/PhD in scientific discipline
- Knowledge of new and developing regulatory and pharmacovigilance expectations
- Knowledge of PS operating model
- Experience of working with third party suppliers.
- Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry