Senior Pharmacovigilance Specialist, Drug Safety

Regulatory Toolkit; Livingston (NJ); Vor Ort; USD 105.000 - 135.000; Vollzeit

Benefits dieser Stelle

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Zusammenfassung

CooperSurgical is seeking a Pharmacovigilance Senior Specialist to support the Pharmacovigilance Manager in overseeing all pharmacovigilance activities and ensuring compliance with FDA regulations and other governing bodies.

The role involves collaboration with QA, Regulatory Affairs, Medical Affairs, and Production, reviewing and auditing cases, maintaining SOPs, and supporting audits and vendor activities. Travel 10–15% may be required.

Qualifikationen

• Knowledge of FDA regulations, ICH guidance, and other regulatory bodies.
• Ability to work with cross-functional teams.
• Proficient in MS Office (Excel, Word, Outlook, PowerPoint).
• Experience with Argus Safety or similar database preferred.
• MedDRA knowledge.

Aufgaben

• Stay up to date with FDA regulations and ICH guidance.
• Assist in development, authoring, and maintenance of Pharmacovigilance SOPs.
• Analyze and monitor all serious, non-serious, listed, and unlisted cases for accuracy and compliance.
• Review and approve device malfunction reports for drug-led products.
• Ensure follow-ups are completed for all cases.
• Assist in aggregate reports and regulatory documents.
• Assist in pharmacovigilance audits of external vendors.
• Perform other duties as assigned.

Kenntnisse

FDA regulations

Multidisciplinary teamwork

Microsoft Office

Argus Safety

MedDRA

Technical reading/writing

English proficiency

Spanish language (plus)

Ausbildung

Bachelor’s degree in health or science

Tools

Argus Safety

Jobbeschreibung

CooperSurgical is seeking a Pharmacovigilance Senior Specialist to support the Pharmacovigilance Manager in overseeing all pharmacovigilance activities and ensuring compliance with FDA regulations and other governing bodies.

The role involves collaboration with QA, Regulatory Affairs, Medical Affairs, and Production, reviewing and auditing cases, maintaining SOPs, and supporting audits and vendor activities. Travel 10–15% may be required.