Drug Safety Associate II

Nature and Scope

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.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• 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.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• 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.

Expected Salary Range:

$95,000-105,000

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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