Detail

Salary
negotiable
Location
Gaithersburg, MD, USA
Posted by: Astra Zeneca
13 Oct
97 Views
12 Dec expires

Senior Director, Oncology Patient Safety

Gaithersburg, MD, USA
Job Description

Our Gaithersburg, Maryland facility creates life-changing medicines for people on a global level. The modern, vibrant scientific campus employs more than 3000 specialists in our field, and it is only a short drive from Washington, DC. It is filled with groundbreaking technology. Our labs spaces were built to facilitate collaboration, interaction and cross functional science. We believe employees benefit from being challenged and encouraged at work. We offer everything from bean bag rooms for creative brainstorming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.

 

Main Responsibilities:

You will recruit, develop, and lead a team of pharmacovigilance scientists and staff, and will provide expert oversight of Safety Strategy and Management Team (SSaMT) input to drug programs, and delivery of critical PV outputs. You will apply your expertise to assure quality deliverables, such as Periodic Reports (PBRERs and DSURs), Health Authority queries, PRAC responses, BLA/NDA/MAA filings, Risk Management Plans, etc. As a change management leader, you will lead and implement strategic change projects across Chief Medical Office Patient Safety therapeutic areas.

 

In addition, you will:

  • Develop objectives for Patient Safety in area of responsibility and ensure these are aligned to broader AstraZeneca goals and objectives.

  • Be an SME for PV regulations/mentorship, leading the Patient Safety Therapy Area

  • Represent and serve as a PV specialist in regulatory agency inspections

  • Share standard methodology across teams within the PS TA and between PS TAs, partnering with other groups as needed

  • Lead PS input into PV Agreements, managing alliance partners for assigned products; may lead due diligence activities

  • Provide strategic safety leadership for complex and ground breaking projects to improve processes within Patient Safety and/or develop and introduce new technologies and approaches at the national, regional or global level

  • Build networks with other PS TAs/teams and external partners to learn about new developments, create opportunities and share best practices, such as benchmarking and Industry forums

  • Partner with PS Center of Excellence to implement changes in PV legislative landscape to prepare appropriate resources and skillsets to address the future

  • Serve as deputy for TA PS VP or Platform Head

  • Participate as a member of the TA Leadership team



Job ID Reference
1531
Desired Skills & Experience

Minimum Requirements:

  • Master’s degree or equivalent qualification in relevant scientific field

  • 10+ years of experience

  • Experience in managing a scientific team.

  • Extensive proven experience in Pharmacovigilance field

  • Knowledge of relevant legislation and developments in the Pharmaceutical industry

  • Experience in either writing Risk Management Plans and assessing risk mitigation activities or in translating preclinical safety experience to man

  • Experience leading strategic projects (Drug and non-drug)

  • Demonstrated ability to influence key partners within and outside of company

  • Demonstrated proficiency with both written and verbal communication

 

Desirable

  • PhD in relevant scientific field

  • Strong network and reputation within the business and industry

  • Extensive knowledge of the latest technical and regulatory expectations

Company
  Gaithersburg, Maryland, USA
  www.astrazeneca.com
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
  Workplace
 Gaithersburg, MD, USA