Pharmacovigilance Senior Specialist

CooperSurgical, Inc.; Illinois; On-site; USD 105,000 - 135,000; Full time

Job summary

CooperSurgical is seeking a Pharmacovigilance Sr. Specialist to support the Pharmacovigilance Manager in overseeing pharmacovigilance activities and ensuring compliance with FDA regulations at our Livingston, NJ site.

You will collaborate with Quality Assurance, Regulatory Affairs, Medical Affairs and Operations to deliver safe, beneficial products and support regulatory pharmacovigilance audits.

Responsibilities

• Assist Pharmacovigilance Manager in oversight of pharmacovigilance activities.
• Collaborate with QA, Regulatory Affairs, Medical Affairs and Production to ensure FDA compliance.

Job description

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

Work location

Livingston, NJ

Scope

The Pharmacovigilance Sr. Specialist is responsible for assisting the Pharmacovigilance Manager in the oversite of all pharmacovigilance activities performed internally at CooperSurgical Inc. and/or by external vendors. The Pharmacovigilance Sr. Specialist will collaborate with a multidisciplinary team including but not limited to external vendors, Quality Assurance, Regulatory Affairs, Medical Affairs, and Production/Operations to ensure CSI is compliant with current FDA regulations and the regulations of other governing bodies.

Job Summary

As a pharmaceutical company, CSI is subject to Pharmacovigilance Audits by the FDA and other regulatory governing bodies. The Pharmacovigilance Sr. Specialist will assist the Pharmacovigilance Manager in ensuring CSI is compliant with current FDA regulations and the regulations of other governing bodies to ensure we consistently deliver safe and beneficial products.

About CooperSurgical CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. Work location: Livingston, NJ