Safety and Pharmacovigiliance Associate

Industry

Health and Safety

Advert ID

USA_450120

Location

Bethesda

Job Type

Permanent

Hours

Full-Time

Salary Range

USD48000-55000 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 ASSOCIATE ( up to 5 positions)

Salary range - $48K - $55K (depending on experience)

REPONSIBILITITES

* Manage and process Serious Adverse Events (SAEs)

* Assist in the preparation of reports

* Generate specified data reports from the database

* Process and review investigator safety reports and notifications for non-IND adverse event reports

* Process and review safety narratives for IND and non-IND Adverse Event cases as required

* Maintain electronic files for the department

* Query SAE databases



REQUIREMENTS

* B.A./B.S. degree in a relevant field, MS degree in related field a plus

* Zero (0) to five (5) years of pharmaceutical, biologics, and/or diagnostic experience

* Drug safety database knowledge required

* Knowledge of GCPs and current federal regulations and guidelines

* Excellent oral and written skills including database experience

* Excellent time management and prioritization skills to meet multiple IND projects' deadlines required

* Knowledge of Microsoft Office