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.
• Â 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
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.
American Regent also offers a 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.
Apply tot his job
Apply To this Job
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.
• Â 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
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.
American Regent also offers a 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.
Apply tot his job
Apply To this Job