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
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.
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
Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:
·All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
·Our recruiting process includes multiple in person and/or video interviews and assessments.
·If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding.
·We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [email protected].
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
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.
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
Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:
·All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
·Our recruiting process includes multiple in person and/or video interviews and assessments.
·If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding.
·We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [email protected].