Detail

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

Principal Pharmacovigilance Scientist

Gaithersburg, MD, USA
Job Description

The Principal Pharmacovigilance (PV) Scientist role provides expertise to multiple and/or single but complex products in different stages of development as needed.  In this role you will provide oversight of safety documents and deliverables for these projects in collaboration with the Global Safety Physician (GSP) and other PV Scientists.  You will lead PV strategy for safety documents and regulatory reports.

 

You will be responsible for leading the strategy for proactive pharmacovigilance and risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.  You will provide subject matter expertise in the therapeutic area and across multiple products.  You may lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization.  You will be performing duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products.  As a Safety expert you will lead presentation of complex issues to Safety Information Review Committee (SIRC).  You will lead safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.  You will lead safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts. You will be leading negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.  You will take accountability and lead resolution of complex safety issues and mediate cross-functional agreement. You may participate in due diligence activities.  You will be responsible to provide training and mentorship to new GSPs and PV Scientists in approved processes and systems.

 

Job ID Reference
1412
Desired Skills & Experience

Essential Requirements

  • 5+ years of directly related PV experience combined with a life sciences/pharmacy/nursing degree, and advanced Patient Safety and/or Clinical/ Drug Development experience.
  • Fluent in written and verbal English
  • Advanced knowledge of PV regulations
  • MD/MSc/PhD in scientific discipline, preferred
  • Advanced understanding of epidemiology, preferred



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