Radius Health, Inc. · 2 hours ago
Manager/Senior Manager Pharmacovigilance Operations
Chesterbrook, PA
Full-time
Hybrid
Senior Level
$140K/yr - $155K/yr
5+ years expRadius Health, Inc. is a global biopharmaceutical company focused on improving patient populations in bone health and related therapeutic areas. The Manager/Senior Manager of Pharmacovigilance Operations will oversee key functions within the Pharmacovigilance Operations group, ensuring compliance and quality in PV activities while collaborating with various departments and external partners.
BiotechnologyHealth CareHealth DiagnosticsPharmaceuticalWomen's
Responsibilities
Manage day-to-day PV operations related to regulatory compliance, quality oversight, and contractual obligations
Monitor and analyze KPIs and compliance metrics; conduct investigations, track deviations, and manage CAPAs within the Quality Management System (QMS)
Maintain inspection readiness for PV activities, including support for audits and health authority inspections
Maintain and update SDEAs and ensure alignment with regulatory expectations and partner agreements
Serve as the PV point of contact for commercial, market research, and patient assistance programs (PAP/PSP), ensuring proper PV language in contracts and delivery of AE/PQC training to third parties
Deliver AE/PQC training to relevant internal and external stakeholders
Maintain and update PV-related SOPs, work instructions (WIs), and job aids (JAs)
Collaborate with global partners to fulfill data requests and information sharing in support of PV obligations
Maintain and track contracts related to PV operations
Act as a subject matter expert on emerging FDA guidelines and regulations, assessing impact on existing procedures and recommending updates
Promote a culture of compliance, operational excellence, and continuous improvement within the PV team
Qualification
Required
Bachelor's degree in Life Sciences or a related field required
Minimum of 5 years of experience in Drug Safety/Pharmacovigilance within the pharmaceutical or biotechnology industry
Demonstrated ability to work collaboratively in a fast-paced, cross-functional, and matrixed environment
In-depth understanding of global PV regulations, including FDA and ICH guidelines
Strong organizational, time management, and project prioritization skills
Excellent verbal and written communication and interpersonal skills
Proven ability to identify issues, analyze root causes, and implement effective solutions
General understanding of risk management and minimization activities
Benefits
Medical, dental and vision benefits
Parental leave
A 401K match
A generous time off plan including two company shutdowns; the week of July 4th and the last week in December
Company
Radius Health, Inc.
We are a biopharmaceutical company dedicated to transforming the future for underserved, global patient populations in bone health and related areas.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.03BKey Investors
MPM Bio IV NVS Strategic Fund
2022-06-23Acquired
2021-03-03Post Ipo Debt· $175M
2017-08-08Post Ipo Debt· $300M
Leadership Team
Bethany Sensenig
Chief Financial Officer & Head of Operations
Recent News
Morningstar.com
2025-10-02
2025-07-31
Company data provided by crunchbase