PV Alliance Management Lead

PV Alliance Management Lead (Associate Director Level Role)

AbbVie

Maidenhead, United Kingdom

The role:

This position reports into the Safety Compliance Team within the Pharmacovigilance and Patient Safety (PPS) organisation. The PPS organisation works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our drugs to protect patients worldwide.

The Pharmacovigilance (PV) Alliance Team is a high-profile high-impact team that owns Safety Data Exchange Agreements and leads the PV Agreement strategy across the product lifecycle. The PV Alliance team plays a critical role partnering with internal stakeholders and external partners across the product lifecycle to ensure appropriate and timely exchange of safety information to maintain regulatory compliance.

Highlighted Responsibilities include:

  • Builds, maintains and develops strategic partnerships with key internal (within and outside PPS) and external stakeholders to advance the department priorities in driving partnership and compliance excellence. Independently executes negotiation of complex, multi-partner PV Agreements with internal stakeholders and external partners within the appropriate timeline;
  • Proactively identifies and escalates potential compliance related issues that may impact the ability to meet regulatory requirements and business goals; leads development and implementation of methods of improvement and resolution;
  • Drives inspection readiness activities by conducting SDEA audit and inspection preparation meetings. May act as the primary contact and subject matter expert for audits/inspections, ensuring document requests and responses are filled in a timely manner;
  • Builds enterprise knowledge around PV alliance processes and systems utilized to create and execute PV Agreements; plans and conducts best practice and knowledge sharing forums with internal stakeholders and external advisory groups;
  • Evaluates and interprets current and emerging legislation, regulations and guidelines that impact Individual Case Safety Reporting (ICSR), Safety Deliverables and other PV requirements; identifies recommended actions (where applicable) to ensure compliance; develops plans and processes for implementation in conjunction with the Business Process Office.

Knowledge and Experience:

  • Significant experience working in the pharmaceutical industry and a strong background in contract negotiation;
  • Proven experience with external partner relationship management;
  • High level of awareness and understanding of pharmacovigilance and drug development; awareness and understanding of legal, compliance and regulatory matters across the product life cycle;
  • Strong leadership presence. Ability to work directly with and influence senior management including internal key stakeholders such as Business Alliance, Legal, Commercial and Quality;
  • Very strong planning and organisational skills and the ability to work independently, effectively and efficiently in a dynamic environment with competing projects and deadlines;
  • Established track record leading cross-functional projects within a global company;
  • A desire to handle complex challenges and find a way!

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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