Pharmacovigilance Senior Specialist
CooperCompanies
Summary
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 description
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.
Travel: This position may require 10-15% domestic and/or international travel.
Qualifications
- 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.
- Experience in the use of the Argus Safety Database or an equivalent database is preferred.
- Working knowledge of MedDRA.
- Ability to read, understand, and write highly technical material.
- Proficient in reading, writing, and communicating in the English language.
- Fluency in Spanish is a plus.
Work Environment: Occasionally lift to 35 pounds. Prolonged periods of sitting, especially in front of a computer.
Experience: 5+ years experience in pharmaceutical or healthcare industry related experience. 3+ years of pharmacovigilance or drug safety related experience.
Education: Bachelor's degree in a health or science field required; Advanced degree preferred.
Requirements
- 5+ years experience in pharmaceutical or healthcare industry
- 3+ years of pharmacovigilance or drug safety related experience
- Bachelor's degree in a health or science field
- Knowledge of current FDA regulations and guidance
- Knowledge of ICH guidance
- Knowledge of regulations and guidance of other regulatory agencies regarding pharmacovigilance and medication safety
- Ability to work with a multidisciplinary team
- Proficiency in 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
Benefits
- Medical coverage
- 401(k)
- Parental leave
- Fertility benefits
- Paid time off
- Vacation
- Personal leave
- Sick leave
- Holidays
Company overview
CooperCompanies (Nasdaq: COO) is a leading global medical device company headquartered in San Ramon, California, with a workforce of over 15,000 employees. The company operates through two primary business units: CooperVision and CooperSurgical. CooperVision is a trusted leader in the contact lens industry, focusing on vision correction and improving daily visual experiences for millions worldwide. CooperSurgical specializes in fertility and women's healthcare, providing innovative medical devices and solutions that support reproductive health and family planning. With products sold in over 130 countries, CooperCompanies positively impacts more than fifty million lives annually. The company generates approximately $4.1 billion in annual revenue and maintains a strong global presence, leveraging its expertise in medical device manufacturing to address critical healthcare needs in both vision care and women's health sectors. CooperCompanies is publicly traded and continues to expand its market leadership through strategic acquisitions, product innovation, and operational excellence.