Pharmacovigilance/safety Associate - Boston, United States - Cardiovascular Clinical Studies

Cardiovascular Clinical Studies
Cardiovascular Clinical Studies
Verified Company
Boston, United States

2 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description
Pharmacovigilance/Safety Associate

Responsibilities of the Pharmacovigilance Associate include but are not limited to:

  • Review of medical records for serious adverse event reporting
  • Writing clinical narratives and FDA MedWatch form 3500 (if applicable)
  • Entering data into Safety Database
  • Working with other safety personnel in cross checking cases as a quality control mechanism
  • Reconciliation of clinical database entries with safety data.
  • Clinical Data listing review with project team
  • Liaise with medical monitor for safety review/finalization of serious adverse events.
  • May participate in medical and concomitant medication coding review
  • Effective communication between site staff, sponsor, internal staff members
  • Participate in project team meetings
  • Knowledge of FDA/GCP/ICH regulatory requirements
  • Knowledge of Excel, Word, and Adobe
  • Other special projects as assigned by Senior Management
Background in nursing or other clinical field required. At least 2 years of Safety experience required.


Job Types:
Full-time, Contract


Pay:
$70, $85,000.00 per year


Benefits:


  • 401(k)
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance

Schedule:

  • Monday to Friday

Ability to Relocate:

  • Boston, MA 02111: Relocate before starting work (required)

Work Location:
Hybrid remote in Boston, MA 02111
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