Safety and Pharmacoviglance Specialist

Industry

Health and Safety

Advert ID

USA_450121

Location

Bethesda

Job Type

Permanent

Hours

Full-Time

Salary Range

USD50000-70000 per year

No. of Openings

1

Branch Information

Bethesda, MD - (USA) 4800 Hampden Lane Suite 200 MD Bethesda , MD - 20814 Phone : 301-215-6346

ContactNumber

301-215-6346

Job Description

SAFETY & PHARMACOVIGILENCE SPECIALIST ( up to 5 positions)

Salary range - $50K - $65k (no experience) - $70K - (foreign medical license and no experience)

RESPONSIBILITIES

*Perform various tasks in support of clinical research including: adverse event analysis and processing, serious adverse event reconciliation

*Preparation of IND safety reports for submission to the FDA

*Safety document or data analysis

*Clinical trial site support



REQUIREMENTS

*M.D. or D.O from a U.S. accredited institution with active U.S. medical license required

*Infectious disease and/or oncology subspecialty highly preferred

*Must have knowledge of GCP and ICH guidelines

*Drug development/clinical trial experience essential

*Knowledge of CTC and/or MedDRA coding preferred

*Experience leading clinical and cross functional teams is a plus

*Must have excellent oral, written, presentation and computer skills

*2+ years of pharmaceutical or biotech industry or academic experience