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. This opportunity will be REMOTE until further notice
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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