Drug Safety Associate II

American Regent, Inc.

1d•$95,000 - $105,000

About The Position

The Drug Safety Associate II will be responsible for the review, evaluation, and management of adverse event (AE) reports for all American Regent Inc., investigational and marketed products under the direction of the Sr. Manager of Pharmacovigilance.

Requirements

Degree in Pharmacy (PharmD) or Nursing (RN) required.
Minimum of 2 years’ experience working in the pharmaceutical industry required, preferably in a Pharmacovigilance Department.
Demonstrated understanding of the assessment and processing of safety reports, including regulatory reporting obligations.
Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA
Team-oriented with excellent accountability, communication, and interpersonal skills.
Flexibility to work in a fast-paced environment for adherence to timelines.
Strong facilitation, organizational, analytical and time management skills.
Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel.

Responsibilities

Perform individual case safety report (ICSR) processing activities within the safety database ensuring quality and timely submission.
Perform quality checks on assigned ICSRs.
Performs reconciliation of safety data.
Participate in Study Team meetings as the Safety and Pharmacovigilance representative.
Support for Audits and Regulatory Inspections.
Support Pharmacovigilance with various ad hoc deliverables or projects as needed.
Provide coverage of dedicated adverse event reporting line during company business hours.
Interact with internal and external customers.
Maintain corporate compliance.
Perform any other tasks/duties as assigned by management.