Regeneron

Healthcare

Director,PharmacovigilanceHub

$183–305k Sleepy Hollow, New York, United States; Warren, New Jersey, United States FULL TIME Remote Friendly
The Brief

“Director, Pharmacovigilance Hub at Regeneron. Skills: Pharmacovigilance, Patient safety, Regulatory compliance. Oversee country/regional PV execution. Ensure local safety activities compliance”

What You'll Achieve.

Ensure timely integration of safety data; Ensure timely resolution of deviations; Ensure timely resolution of non-compliance; Provide high quality adverse event reports

Industry & Context.

Healthcare
Problems you'll solve

Issue resolution; Risk mitigation

What They're Looking For.

Must Have

Bachelor's Degree, 12+ years PV experience, Demonstrated achievements in patient safety, Experience supporting regulatory inspections, Experience supporting audits, Experience supporting quality issue management at country or regional level

Nice to Have

Advanced Degree, Experience with AI technologies

What You'll Do.

Oversee country/regional PV execution

Ensure local safety activities compliance

Meet local regulatory requirements

Integrate country-generated safety data

Serve as escalation point

Act as conduit between local operations and global

Maintain understanding of local legislation

Keep leadership informed of updates

Track local process status

Drive continuous improvement

Maintain and monitor via common tool

Develop innovative approaches

Integrate new technologies

Ensure country compliance with global PV quality system

Resolve non-compliance

Serve as local safety PoC

Coordinate with global GPS teams

Coordinate with non-GPS teams

Guide global teams on local requirements

Ensure compliance with local legislations

Coordinate with other PV hub(s)

Contribute to activities

Contribute to local documentation

Shape compliant programs

Provide high quality adverse event reports

Build a high-performing team

Coach a high-performing team

Scale a high-performing team

Drive succession planning

Drive talent pipelines

How You'll Work.

Team & Collaboration

Cross-functional teams; Global oversight functions; Global GPS teams; Non-GPS teams

Free ATS check

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