Under the supervision of the Director of Pharmacovigilance (PV) Operations, the Sr. Manager/Associate Director, Pharmacovigilance Operations will support day-to-day Scholar Rock Safety Operations activities. The individual will provide oversight and management of vendors, business partners, contracting and Individual Case Safety Report (ICSR) activity, as applicable, to ensure efficiency, quality, and compliance with internal procedures and global regulations. They will also contribute to compilation of metrics, support daily/weekly Department meetings and support individual study teams and collaborate on the support of risk management and pharmacovigilance activities for all Scholar Rock products. Additionally, they will contribute to the planning, execution, and implementation of process improvements, procedures, and solutions related to Scholar Rock pharmacovigilance and ICSR and Aggregate reporting.

Position 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

Candidate Requirements:

• • Bachelor’s degree (preferably in a science or health-related field) and a master preferred
  • 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
  • Experience of Oracle Argus Safety is preferred
  • 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