Senior Manager, Pharmacovigilance Operations

Summary

Join Scholar Rock, a biopharmaceutical company focused on developing life-changing therapies, as a Sr. Manager/Associate Director, Pharmacovigilance Operations. Under the supervision of the Director of Pharmacovigilance (PV) Operations, you will oversee vendor management, ensure compliance with global regulations, and manage Individual Case Safety Reports (ICSRs). You will contribute to metric compilation, support departmental meetings, and collaborate on risk management and pharmacovigilance activities. Responsibilities include process improvement, procedure implementation, and support for departmental inspections. This role requires strong project management skills and experience in pharmacovigilance operations.

Requirements

• Bachelor’s degree (preferably in a science or health-related field)
• A minimum of 3 years of experience in Pharmacovigilance with strong experience preferred in Pharmacovigilance Operations and/or PV affiliate Operations
• Strong working knowledge of PV regulations and PV processes
• Proficiency with standard desktop computing programs (e-mail, Word, Excel) and relational databases
• Excellent Project Management and interpersonal skills, results oriented and strong attention to detail
• Ability to manage multiple, complex projects in a fast-paced environment with capacity to prioritize, plan and organize work assignments under strict timelines

Responsibilities

• Oversees PV vendors/service providers to ensure that they fulfill their accountabilities and responsibilities for all outsourced PV activities – case processing and reporting
• Participates in study activities as a PV Project Manager, from study start-up through conduct and study wrap-up. Serves as operational safety lead on all relevant study-related activities, attends routine and ad-hoc study meetings, establishes, maintains and executes roles within the Safety Management Plans/Expedited and Periodic Safety Reporting Plans
• Acts as a Subject Matter Expert (SME) regarding the processing and reporting of Individual Case Safety Reports (ICSRs) for Scholar Rock products and participates in meetings with outsourced vendors
• Contributes to maintenance of metrics, Key Performance Indicators (KPIs) and related quality activities
• Assists in preparing, facilitating and documents Department activities, including weekly Safety team meeting, and other ad hoc discussions and decision, as applicable
• Supports and/or contributes to Departmental Inspection readiness, where applicable, including but not limited to author/contribute to controlled document preparation and administrator
• Supports budget/contract review process, serving as administrator, negotiator, QC, as directed
• Assists in maintenance of Department archive of safety documents, including relevant communications and other key documents
• Supports safety-governance-related activities, including scheduling and documentation, where applicable, of Product Safety Committee (PSC), Executive Safety Committee (ESC) or ad-hoc meetings
• Collaborates with and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives
• Collaborates with corporate partners to ensure proper exchange of drug-safety data, developing associated plans

Preferred Qualifications

• Master's degree
• Experience of Oracle Argus Safety