Associate Director, Pharmacovigilance Processes, Partnerships and Contracts
AstraZeneca

Gaithersburg, Maryland

Posted in Pharmaceuticals


This job has expired.

Job Info


Are you excited about Patient Safety? Would you like have an impact on patients' lives and contribute to eliminate cancer as a cause of death? If so then join us!!

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.

Business area

Here we don't just put the patient first - we put the patient and those affected by cancer at the very heart of everything we do. From families to caregivers, we make a positive difference for as many people as possible.

Patient Safety Centre of Excellence (PS CoE) - Powering AZ to consistently achieve pioneering Patient Safety. The PS CoE is a centralized group of niche experts driving excellence across PS. We establish standards, provide scientific solutions and lead innovation.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!

What you'll do

This role will work in the Pharmacovigilance Processes, Partnerships and Contracts (PV PP&C) area, negotiating optimal safety agreements and contracts for AstraZeneca whilst establishing excellent collaborations and maintaining positive working relationships with third party partners (i.e. Licensing Partners). Responsibilities include, but are not limited to:

  • Negotiating optimal, compliant, Pharmacovigilance (PV) Agreements for AstraZeneca whilst establishing excellent collaborations and maintaining positive working relationships with third party partners (i.e. Licensing Partners
  • Providing customers with advice, guidance and interpretation of matters pertaining to PV Agreements to demonstrate the value of Patient Safety as a key contributor to AstraZeneca 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 License Partner 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
  • Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy
  • Manages relationships/partnerships/alliances external to the AstraZeneca PS CoE function that are essential to delivering AstraZeneca's 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
  • Lead the development and/or enhancement of standards or techniques in order to improve the quality, compliance and efficiency of deliverables for the overall group

Required Experience, Skills, and Qualifications
  • A science/pharmacy/nursing degree or equivalent experience with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
  • Experience in working cross-functionally and shown ability to work across cultures
  • Leadership skills, including 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
  • Collaboration, negotiation, conflict management and interpersonal skills
  • Ability to influence whilst maintaining an independent and objective view

Desired requirements
  • MSC/PhD in scientific field
  • Knowledge of new and developing regulatory and pharmacovigilance expectations
  • Knowledge of existing AstraZeneca external alliances and collaborative projects
  • 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

Why AstraZeneca

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next:

Are you already envisioning yourself joining our team? Good, because we can't wait to hear from you.

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.


This job has expired.

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