New · posted Oct 31
CooperCompanies · Medical Devices
Pharmacovigilance Senior Specialist
- Livingston, NJ +1 more
- On-site
- Full-time
- Senior & Principal
The role
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.
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.
What you need
Education
- Bachelor’s degree in a health or science field required; Advanced degree preferred.
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.
Experience
- 5+ years experience in pharmaceutical or healthcare industry related experience.
- 3+ years of pharmacovigilance or drug safety related experience.
Pay
$105,000 – $135,000 a year
Employer providedFor U.S. locations that require disclosure of compensation, the starting base pay for this role is between $105,000.00 - $135,000.00 annually. The actual base pay includes 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.
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.
Where you'll work
Livingston, NJ +1 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: Trumbull, CT
More jobs in Livingston, NJ +1 moreWorking conditions
Travel
This position may require 10-15% domestic and/or international travel.
- Occasionally lift to 35 pounds.
- Prolonged periods of sitting, especially in front of a computer.
From the posting
About CooperCompanies
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.
Equal opportunity, accessibility and legal noticesCooperCompanies's statements, word for word
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
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.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 35% below the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Senior & Principal roles in the US9 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $105,000 | — | $135,000 |
| All US (middle half) | $145,000 | $186,000 | $201,500 |
This role: CooperCompanies's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 113 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not CooperCompanies's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance6
- Documentation and SOPs4
- Collaboration and leadership3
- Data and digital systems1
Company hiring pulse
CooperCompanies on Regulatory Jobs
- 13
- Open roles
- 13
- Distinct roles
- 6
- Locations
By discipline
- Quality11 85%
- Regulatory1 8%
- Clinical1 8%
By level
- Senior & Principal10 77%
- VP & Executive1 8%
- Manager1 8%
More roles at CooperCompanies
- View role
Quality Assurance Coordinator
Henrietta, NYAssociate & SpecialistMedical Devices$42K–$48K
- View role
Quality Engineer Senior
Trumbull, CTSenior & PrincipalMedical Devices$96K–$129K
- View role
Staff Design Quality Engineer
Trumbull, CTSenior & PrincipalMedical Devices$118K–$150K
- View role
Vice President, Regulatory Affairs
Trumbull, CTVP & ExecutiveMedical Devices$220K–$350K
Pharmacovigilance Senior Specialist at CooperCompanies
Open until filled. $105K–$135K a year, employer provided.