Pharmacovigilance Quality Sr. Specialist

Nature and Scope

Pharmacovigilance Quality and Compliance Specialist provides critical support to the PV Team under the direction of the Pharmacovigilance Sr. Director.

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 quality review of responses to FDA requests.
• Develop quality metrics and prepare periodic reports based on metrics and quality trends.
• Periodic reporting of trends to Management to identify areas of non-compliance and implement corrective actions/risk based activities to mitigate risk of future occurrence.
• Participate in the CAPA process and ensure reported deviations and incidents are properly managed and escalated.
• Support inspection readiness activities.
• Provide Operational support during internal process audit activities
• Keep abreast of regulatory requirements, and update local management on the possible ramifications of regulatory changes and impact of compliance risk (if any) on current processes.
• 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.

• 4-year degree BA/BS in the life sciences, required.
• At least 2 years of relevant pharmaceutical industry experience, including exposure to quality and compliance activities.
• Minimum of 3 years of experience working in the pharmaceutical industry, preferably in a Pharmacovigilance Department, required.
• Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
• Attention to detail and excellent communication skills (oral and written) a must.
• Ability to multi-task and excel in a matrix environment.

Excellent computer skills (Microsoft Word, Excel, Outlook).

Expected Salary Range:

$95,000-115,000

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

American Regent Inc. endeavors to make https://americanregent.com/Careers 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 hrtalentacquisition@americanregent.com.