Pharmacovigilance Senior Specialist

CooperCompanies•Livingston, NJ

2d•$105,000 - $135,000•Onsite

About The Position

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. 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.

Requirements

Must have knowledge of current FDA regulations and guidance, ICH guidance, and the regulations and guidance of other regulatory agencies regarding pharmacovigilance and medication safety.
Ability to work with a multidisciplinary team and establish working relationships both internally and externally.
Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.
Working knowledge of MedDRA.
Ability to read, understand, and write highly technical material.
Proficient in reading, writing, and communicating in the English language.
5+ years experience in pharmaceutical or healthcare industry related experience.
3+ years of pharmacovigilance or drug safety related experience.
Bachelor’s degree in a health or science field required.

Nice To Haves

Experience in the use of the Argus Safety Database or an equivalent database is preferred.
Fluency in Spanish is a plus.
Advanced degree preferred.

Responsibilities

Responsible for staying up to date with current FDA regulations, ICH guidance, and guidance of other regulatory governing bodies regarding Pharmacovigilance.
Assist the Pharmacovigilance Manager in the development, authoring, and maintenance of Corporate Pharmacovigilance Standard Operating Procedures (SOPs).
Analyze and monitor all serious, non-serious, listed, and unlisted cases for accuracy, consistency, and compliance with all regulatory requirements.
Review and approve device malfunction reports for a drug-led combination product.
Ensure all necessary follow-ups are performed for all cases through case completion.
Assist in the review of aggregate reports and other regulatory documents as needed to meet the required deadlines.
Assist the Pharmacovigilance Manager with performing pharmacovigilance audits of external vendors as required.
Perform other duties as assigned.