Principal PV Processes and Partnerships

Job title : Principal PV Processes and Partnerships
Location : Cambridge
Job type : Contract/Freelance
Salary : Negotiable
Contact name : Pauline Markina
Contact email : pauline.markina@secpharma.com
Employment type: Contract
Location: Cambridge (remote until offices reopen)
Duration: 3 months

Job description:

Working with the Processes and Partnership (P&P) leads in PV Processes, Partnerships and Contracts group, taking responsibility for the management of assigned projects, processes and partnerships including implementation, communication, compliance, performance and inspection readiness.

Accountable to develop relationships across Patient Safety to execute the delivery of the processes and partnership strategy, priorities, alongside governance and management of the current procedural documents and partnerships.

Typical accountabilities:
* Identify opportunities for and drives the enhancement of existing processes and partnerships through knowledge of internal and external environment.
* Working with the PV P, P&C leads, and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
* Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
* Manages relationships/partnerships/alliances that are essential to delivering pharmacovigilance and regulatory LTO responsibilities
* Using deep understanding of regulatory and pharmacovigilance processes and regulations provide process or compliance support to safety and regulatory teams and submissions.

Requirements:
* A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
* Experience working with PV processes, partnerships, and agreements/contracts
* Experience in working cross-functionally
* Leadership skills, including proven leadership of project teams experience
* Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues
* Thorough knowledge of the drug development process
* Good attention to detail
* Excellent written and verbal communication skills
* Proven ability to work across cultures