Safety and Pharmacovigilence Specialist Job at Beacon Hill (Bethesda)

Job Description

SAFETY & PHARMACOVIGILENCE SPECIALIST (2 positions). Hybrid position-2 days in Bethesda, MD office-Mondays/Wednesdays, or Tuesdays/Thursdays-chosen by supervisors. Working hours-8am-4:30pm, or 5pm (Depending on if you take a half hour our hour-long lunch break). Contract Term: 6 months (1000 hrs) to permanent.

Job Responsibility

Ensures compliance with Standard Operating Procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to regulatory agencies
Develops and ensures the uniform and timely processing of adverse event reports
Provides medical evaluation of adverse event reports
Performs various tasks in support of clinical research including the reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development
Maintains/updates agent-specific clinical and preclinical toxicity study summary tables for investigational agents
Performs literature searches
Performs 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
reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development
Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labeling/package inserts, and other reports as necessary
May review experimental protocols and informed consent documents
and prepare, review, and edit presentations regarding safety issues

Requirements

US OR Foreign Trained MDs (MBBS) – with clinical practicing experience
Ideal candidate will have all three, MD + Clinical Practicing experience + clinical research
Strong written and oral communication skills
Knowledge of GCP and ICH guidelines preferred
drug development/clinical trial experience essential
Knowledge of safety databases 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 academic, pharmaceutical or biotech industry or academic experience

Nice to have

Knowledge of GCP and ICH guidelines
Knowledge of safety databases and/or MedDRA coding
Experience leading clinical and cross functional teams

Beacon Hill - All Job Offers

Select Country

Safety and Pharmacovigilence Specialist

Job Description

Job Responsibility

Requirements

Nice to have

Looking for more opportunities?

Safety and Pharmacovigilence Specialist

Senior Physician, Patient Safety

Senior Patient Safety Specialist

Patient Safety Associate II/Patient Safety Specialist - Japanese

Senior Pharmacovigilance Specialist

Local Safety Specialist

Principal Physician, Patient Safety

Senior Specialist, Social Media PV CoE

Case Specialist-Pharmacovigilance

Our AI answers in your language