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Pharmacovigilance Scientist

Company:
Artech Information Systems
Location:
Gaithersburg, Maryland, United States
Posted:
February 22, 2018
Description:

Job Description:

Posting Title: Pharmacovigilance Scientist

Job Id: AZNJP00004521

Location: Gaithersburg, MD

Duration: 8 Months

Responsibilities:

The Pharmacovigilance (PV) Scientist supports the Global Safety Physician (GSP) and (Senior/Principal) PV Scientist with the review of safety data and related documents to identify and escalate potential safety issues. He/she has the ability to provide the first draft of safety documents and regulatory reports, and will participate in meetings, as necessary.

Main Responsibilities:

• Supports proactive pharmacovigilance and risk management planning for designated products, including project managing preparation of the safety aspects of the global Risk Management Plans, in partnership with the Global Safety Physician (GSP) and (Senior/Principal) PV Scientist, as appropriate.

• Provides patient safety input to pivotal study documents, for example Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.

• Runs/supports routine signal detection processes in partnership with the GSP, for all products in area of responsibility.

• Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals. Creates first draft of documents with clear conclusions in response to internal or regulatory authority requests for safety data.