Detail

Salary
negotiable
Location
Gaithersburg, MD, USA
Posted by: Astra Zeneca
15 Oct
56 Views
14 Dec expires

Pharmacovigilance Science Director - RIA

Gaithersburg, MD, USA
Job Description

As a Pharmacovigilance Science Director in Respiratory, Inflammation, Autoimmune, Infection & Vaccines in Gaithersburg, MD, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on patient’s lives.  You will join us in driving development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.  You will be representing the voice of patients in the development, maintenance and use of our medicines.

AstraZeneca holds a unique position in Respiratory Disease, including asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), with a range of differentiated potential medicines in development, leveraging novel combinations, biologics and devices. The pipeline also has a number of promising assets in inflammatory and autoimmune diseases, and infection/vaccine products. 

 

Main Duties and Responsibilities

In the PVSD role you will recruit, develop, and manage 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 PV outputs. You will apply your expertise to assure quality deliverables, such as Periodic Reports (PBRERs and DSURs), Health Authority queries, PRAC responses, etc.  As a change management leader, you will lead and implement strategic change projects across Chief Medical Office Patient Safety therapeutic areas. 

 

In addition, the PVSD will…

  • Serve as subject matter expert for PV regulations/guidance, and leading the PS TA in regulatory agency inspections 
  • Share best practice across teams within the PS TA and between PS TAs, partnering with other groups as needed
  • Lead PS input into PV Agreements and serve as lead for managing alliance partners for assigned products; may lead due diligence activities
  • Lead, manage or support complex and cutting-edge 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 stakeholders to learn about new developments, leverage opportunities and share best practices, such as benchmarking and Industry forums
  • Serve as deputy for TA PS VP
  • Participate as a member of the TA Leadership team
Job ID Reference
1411
Desired Skills & Experience

Essential Requirements

  • Master’s degree or equivalent qualification in relevant scientific discipline
  • Experience in managing a scientific team
  • Extensive industry 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 in leading complex strategic projects (Drug and non-drug)
  • Demonstrated ability to influence key stakeholders within and outside of company
  • Demonstrated proficiency with both written and verbal communications

 

Preferred

  • PhD in relevant scientific discipline
  • Expert 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