Clinical Safety Management Physician - Gaithersburg, MD | Biospace
Get Our FREE Industry eNewsletter

Clinical Safety Management Physician

AstraZeneca Pharmaceuticals LP

Gaithersburg, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location:Gaithersburg, Maryland, United States
Gothenburg, Västra Götaland, Sweden
Job reference: R-010061

Posted date: Jul. 06, 2017

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Clinical Safety Management Physician in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

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 by leveraging novel combinations, biologics and devices. The pipeline also has a number of promising assets in inflammatory and autoimmune diseases within areas such as psoriasis, psoriatic arthritis, gout, systemic lupus and rheumatoid arthritis

Main Duties and Responsibilities

As the Clinical Safety Management Physician you will serve as a trial level physician to support the design, implementation and interpretation of clinical studies with a focus and expertise on Patient Safety/Pharmacovigilence. You will conduct medical review of individual case safety reports, writing medical assessments for cases, querying for additional medical information needed to understand the event and determine causality. You will be performing aggregate review of cases. You will be responsible for communication of any identified safety signals, and data analysis to Safety Management Team. You will lead or participate as a member of Clinical Safety Management matrix-teams and other product teams.

You will provide oversight and key input for review of new or on-going safety documents that ensure compliance with domestic and international regulatory requirement. You will manage / lead and contribute to the GMed component of the aggregate safety reports. Collaborates with other departments to ensure appropriate collection and handling of safety data. You will work closely with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations. You will provide expert medical input into the preparation of regulatory documents,expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature. You will participate in the preparation of publications and presentations at scientific meetings and congresses.


Essential Requirements

  • Fully qualified physician with pharma industry experience in late stage respiratory drug development.
  • You have significant experience in the design, execution and interpretation of clinical trials in the respiratory area, particularly in Respiratory biologics clinical development
  • Experience in clinical trial safety oversight and management
  • Experience reviewing new and ongoing safety documents such as Investigator Brochures, protocols, clinical study reports, ICF etc.
  • Experience with aggregate safety reports such as Periodic Benefit Risk Evaluation Report (PBRER), Investigational New Drug (IND), New Drug Application (NDA), Developmental Safety Update Report (DSUR) and other periodic reports
  • Experience in the creation of risk management plans (RMP), Investigator Brochures (IB), Summary of Product Characteristics (SmPC), Package Insert (PI) and other label updates
  • You have good teamwork and collaboration skills
  • You have good verbal and written communication skills in English
  • You are able to travel nationally and internationally

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.