PIPER
Published
May 26, 2021
Location
BETHESDA, MARYLAND
Category
Job Type
Work Setting
Remote / Home-based, In-office

Description

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

TMF, eTMF, Electronic Trial Master File, Trial Master File, CRO, Contract Research Organization, FDA, Regulation, Regulatory, CRA, Clinical Research Associate, ICH, GCP, SOP, Standard Operating Procedure, regulatory file review, agenda preparation, Microsoft Office, MS Word, Excel, Outlook, IRB, Internal Review Board, IRB Submission, Regulatory Coordinator, Pharmaceutical, OHRP regulations, clinical trial, human subjects, Veeva Vault, Site Initiation Visit, database, drug development, Pharmaceutical, Biotech, Academia, Investigational New Drug, IND, Adverse Events, AE, Serious Adverse Events, SAE

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