Safety & Pharmacovigilance Specialist

Location
Bethesda, MD
Salary
Up to $100k Based Upon Experience
Posted
Apr 05, 2021
Ref
CR
Required Education
Doctorate/PHD/MD
Position Type
Full time

Piper Companies is currently seeking a Safety & Pharmacovigilance Specialist for an opportunity in Bethesda, MD. The Safety Specialist will be joining a CRO who supports Clinical Trials that are looking to bring new Drugs and Vaccines to the marketplace.

 Responsibilities of the Safety & Pharmacovigilance Specialist:

  • Preform Adverse Event (AE) analysis and processing. Reconciliation of any Serious Adverse Events (SAE).
  • Prepare all Investigational New Drug (IND) reports for submission to the FDA.
  • Trial Site support such as safety documentation or data analysis.
  • Collect, share, and report any results or issues around all Adverse Events (AE) for currently marked drugs and drugs in experimental stages.
  • Edit, prepare, and review all presentations regarding safety of the Clinical Trial.

Qualifications of the Safety & Pharmacovigilance Specialist:

  • M.D. or Ph.D. from an accredited University with active U.S. medical license or ECMFG certification required.
  • 2+ years of clinical trial experience in the pharmaceutical, biotech or academic industry.
  • Knowledgeable about GCP and ICH guidelines
  • Knowledge with CTC or MedDRA coding highly preferred
  • Experience in Infectious Disease or Oncology Drug Development or Clinical Trials.

Compensation for the Safety & Pharmacovigilance Specialist:

  • Salary Range: Up to $100,000 Based upon experience
  • Comprehensive Benefits: Medical, Dental, Vision, and 401K

 

 

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