[Hiring] Drug Safety Associate II @American Regent, Inc.
Role Description 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.
- Perform individual case safety report (ICSR) processing activities within the safety database ensuring quality and timely submission.
- Perform quality checks on assigned ICSRs.
- Perform 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.
Qualifications
- 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.
Requirements
- Expected Salary Range: $95,000-105,000
- The salary range is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
Benefits
- Competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.
Company Description
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.
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[email protected] before responding.
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