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Pharmacovigilance Scientist
Ref No.: 18-02332
Location: Gaithersburg, Maryland
Start Date / End Date: 02/26/2018 to 10/05/2018
DESCRIPTION:
Artech is currently seeking to add to the below position
 
Job Description:
Posting Title:  Pharmacovigilance Scientist
Job Id:               AZNJP00004521
Location:          Gaithersburg, MD
Duration:          8 Months
 
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
• In consultation with the GSP and Clinical representatives, drafts the Reference Safety Information (RSI) for assigned development products; coordinates meetings and tracks timelines to ensure completion. 
Provides input to periodic regulatory documents (e.g. PBRERs, PSURs, and DSURs) according to the agreed processes and timelines. 
• Provides patient safety input to the global regulatory submissions for new products, formulations or indications (e.g. NDA, BLA, MAA), in partnership with GSP and (Senior/Principal) PV Scientist and in liaison with other functional experts. 
• Raises appropriate concerns/issues to senior staff in a timely manner. 

Requirements – Education and Experience: 
• A life sciences/pharmacy/nursing degree, and advanced Patient Safety and/or Clinical/ Drug Development knowledge. 
• Fluent in written and verbal English 
• Basic awareness of Pharmacovigilance regulations 
• MD, MSc/PhD in scientific discipline, preferred
 
 
Please apply on our company website (www.artechinfo.com) with reference to job ID, or contact me at nisha.samuel@artechinfo.com / 973.967.3540
 
Nisha Samuel
Assistant Manager- Staffing

Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3540 | Fax: 973.998.2599
Email: Nisha.Samuel@artechinfo.com | Website: www.artechinfo.com

 
About Artech Information Systems LLC
Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Women-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check: www.artechinfo.com
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