Radius Health, Inc.

Compensation

Full Description

Radius Health is a global biopharmaceutical company dedicated to transforming the future for patient populations in bone health and related therapeutic areas. Our team works relentlessly to improve the lives of our patients, their caregivers, our communities, our partners, and each other. We live by our corporate values, and every employee has an unwavering commitment to contributing to our positive culture. We are currently recruiting for a Manager/Senior Manager, Pharmacovigilance Operations. This role may be considered at a Senior Manager level, depending on years of experience and qualifications. Job Summary: The Manager/Sr. Manager, Pharmacovigilance (PV) Operations will support and oversee key functions within Radius’ Pharmacovigilance Operations group. This role is responsible for tracking, analyzing, and reporting key performance indicators (KPIs) to monitor the quality and compliance of the PV system. The individual will lead the oversight of compliance-related activities, including ICSR submission timelines, reconciliation processes, SOP and WI management, and Safety Data Exchange Agreements (SDEAs). Additionally, this role will support periodic safety report submissions, inspection readiness, and cross-functional collaboration across Medical Affairs, Quality, Regulatory, Legal, Commercial, and Medical Information, as well as with external service providers and global partners. The Manager/Sr. Manager will ensure day-to-day activities are aligned with company standards and regulatory requirements, with a strong focus on quality, compliance, and continuous improvement. This position reports to the Senior Director, Pharmacovigilance Operations. Responsibilities include but are not limited to: • 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. Experience and Qualifications: • 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. Work Environment: The work is performed primarily in a remote office environment with occasional required in person office work, meetings, and/or travel. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee is required to utilize audio visual programs for frequent meetings and discussions with fellow employees, vendors, outside agencies and/or customers. The employee may lift and/or move up to 10 pounds occasionally. Equal Opportunity Employer Statement Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetics, or protected veteran status. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. At Radius Health, Inc. we have a commitment to our culture and to our employees’ well-being and work-life balance. We support this mission by offering a compensation package with medical, dental and vision benefits. We also provide parental leave, a 401K match and a generous time off plan including two company shutdowns; the week of July 4th and the last week in December. We are proud to provide a competitive salary range for the Manager/Senior Manager, Pharmacovigilance Operations role, which is $140,000 - $155,000. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.