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Pharmacovigilance (PV) Scientist
Ref No.: 18-00048
Location: Gaithersburg, Maryland
Position Type:Contract
Start Date / End Date: 02/26/2018 to 10/05/2018
PHARMACOVIGILANCE (PV) SCIENTIST
GAITHERSBURG, MD

Project Description:
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.
  • 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.

Required Skills:
  • 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.


This 8+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Karen: karen@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00048
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE