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Townsend & Associates

Pharmacovigilance Scientist

Post Date:Oct 02, 2018Type:Contractor
Start Date:10/2/2018Salary:
Location:US-PA-Swiftwater, PA Job Reference:18-01693
Skills:

Pharmacovigilance Scientist

W2 ONLY!! 

Qualifications:

  • Minimum Bachelors of Science or Health Care Professional (RN, BSN, Nurse Practitioner or Physician Assistant, RPh); or preferred advanced health care discipline degree (MDPharmD, PhD, Masters of Science, etc.) or equivalent qualification.
  • Certifications & Licenses: Nurse Practitioner, Physician Assistant, RN.
  • Preferred 2 years with relevant experience (including industry experience) with a working knowledge of drug safety and risk management, and understanding of drug development, basic knowledge of regulatory guidelines and medical coding (i.e. MedDRA).
  • Basic knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems.
  • Good knowledge of pharmacovigilance practices.
  • Good knowledge of US and EU pharmacovigilance regulatory requirements.
  • Ability to present and critically discuss safety data in both internal and external discussions.
  • Ability to evaluate, interpret and synthesize scientific data (analytical thinking).
  • Healthcare experience with knowledge of adverse events.
  • Pharma/Biotech experience a plus.

Pharmacovigilance Scientist



Job Description:

Pharmacovigilance Scientist
Responsibilities:

  • Serve as a core member of the safety team and is responsible for performing proactive pharmacovigilance activities on a product, or group of products in a therapeutic area or franchise, in partnership with the Global Safety Officer (GSO) to evaluate safety data and signals for both marketed products and products in clinical development.
  • Perform signal detection and safety management committee activities.
  • Authoring safety evaluations.
  • Contribute and review of aggregate safety reports.
  • Assist with ad hoc regulatory responses.
  • Facilitate signal management process for assigned products (i.e., signal tracking, data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO and Pharmacoepidemiology.
  • Support the GSO with other safety related activities associated with new drug applications / regulatory filings, benefit risk assessment and safety risk management and support activities related to risk minimization including dRMP/RMP and REMS.
  • Provide coordination and oversight to outsourced activities (i.e., signal detection reports, clinical overviews).

Pharmacovigilance Scientist





Contact Information
Townsend & Associates
Name: careerbuilder.townsend-associates@jobdivaemail.com
Ph: 973-984-7900


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