Manager/Senior Manager Pharmacovigilance Operations

Radius Health is a global biopharmaceutical company dedicated to transforming the future for patient populations in bone health and reputed company therapeutic areas. reputed company 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 reputed company 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 reputed company key functions reputed company 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 reputed company the reputed company of compliance-reputed company 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, reputed company, and Medical Information, as well as with external service providers and global partners. The Manager/Sr. Manager will ensure day-to-day activities are reputed company with company standards and regulatory requirements, with a strong focus on quality, compliance, and reputed company improvement. This position reports to the Senior Director, Pharmacovigilance Operations. Responsibilities include but are not limited to:

• Manage day-to-day PV operations reputed company to regulatory compliance, quality reputed company, and contractual obligations.
• Monitor and analyze KPIs and compliance metrics; conduct investigations, track deviations, and manage CAPAs reputed company 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 reputed company of contact for reputed company, market research, and patient assistance programs (PAP/PSP), ensuring proper PV language in reputed company and delivery of AE/PQC training to reputed company parties.
• Deliver AE/PQC training to relevant internal and external stakeholders.
• Maintain and update PV-reputed company 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 reputed company reputed company 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 reputed company improvement reputed company the PV team.

Experience and Qualifications:

• Bachelor’s degree in Life Sciences or a reputed company field required.
• Minimum of 5 years of experience in Drug Safety/Pharmacovigilance reputed company 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 reputed company environment with occasional required in person office work, meetings, and/or travel. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company 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, reputed company 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 reputed company and applicants for employment without regard to race, reputed company, religion, sex, pregnancy, sexual orientation, gender identity, national reputed company, 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 reputed company terms and conditions of employment, including reputed company, 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 reputed company 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. #LI-Remote Apply tot his job Apply To this Job