Pharmacovigilance Senior Specialist

Regulatory Jobs; Livingston (NJ); Sur place; USD 105 000 - 135 000; Plein temps

Avantages offerts par ce poste

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

FDA regulations

Multidisciplinary teamwork

Microsoft Office

Argus Safety

MedDRA

Technical reading/writing

English proficiency

Spanish language (plus)

Formation

Bachelor’s degree in health or science

Outils

Argus Safety

Description du poste

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:

Trumbull, CT or Livingston, NJ (on-site)

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.

• 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.

Knowledge, Skills and Abilities:

• 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.

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Our Benefits:

As an employee of CooperSurgical, you’ll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation, the starting base payfor this role is between$105,000.00 - $135,000.00 annually. Theactual base payincludes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.