Director, Senior Director, Pharmacovigilance Operations

Summary

Join Scholar Rock, a biopharmaceutical company focused on developing life-changing therapies, as the Director/Sr Director of Pharmacovigilance (PV) Operations. You will be the lead contact for PV Operations, directing daily activities, managing vendors, and ensuring compliance with global regulations. Responsibilities include developing PV strategies, overseeing ICSR reporting, managing projects, and ensuring the integrity of safety databases. You will also lead safety vendor planning, facilitate aggregate safety reporting, and contribute to department activities. This role requires strong project management skills, experience in PV operations, and a deep understanding of PV regulations. The ideal candidate will possess excellent communication and interpersonal skills and be able to manage multiple complex projects in a fast-paced environment.

Requirements

• Bachelor’s degree or Nursing equivalent (preferably in a science or health-related field) and a masters preferred
• A minimum of 7 years of experience in PV Operations
• Strong working knowledge of PV regulations and PV processes
• Proficiency with standard desktop computing programs (e-mail, Word, Excel, PowerPoint) and relational databases
• Excellent Project Management, oral/written/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
• Able to be diplomatic, tactful and detail-oriented with exceptional critical reasoning skills. Able to deal with ambiguity and demonstrate a creative and pragmatic approach to problem solving

Responsibilities

• Directs PV Operations activities and resources
• Manages PV vendors and primary contact for business partners
• Develops and implements the strategy for PV systems and processes
• Ensures compliance with global AE/SAE case processing and reporting requirements for all clinical products in development and potential future post-marketing programs
• Directs cross-functional and safety vendor training on ICSR activities, safety procedures and processes
• Develops and monitors quality ICSRs reporting metrics (includes monitoring of key performance indicators and quality metrics of PV staff for outsourced PV activities) to promote PV compliance
• Manages projects, from study start-up through conduct and study close-out. 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
• Directs the initiation and performance of the Safety Database system for each study (and potential future post-marketing) for optimal integrity, accuracy and completeness of processing in preparation for applicable reporting to the Regulatory Authorities (RA), Study Investigators, Ethics Committees (ECs) and Institutional Review Boards (IRBs)
• Responsible for PSMF and interface with RPPV e.g., QPPV/LPPV network
• Facilitates submissions of all aggregate safety reporting and Suspected Unexpected Serious Adverse Reactions (SUSARs) for Regulatory requirements and site distribution within the required reporting timelines
• Leads outsourced PV vendor activities and ensures deliverables are met in a timely manner amongst Scholar Rock PV team, other functional teams and including various company vendors
• Contributes to department activities, including weekly safety team meeting, and other ad hoc discussions and decision
• Manages departmental Inspection readiness, organizing PV documentation and procedural documents (e.g., Standard Operating Procedures (SOPs), Safety Management Plans (SMPs), Data Entry Guidelines (DEGs), SAE and Pregnancy collection Forms/Guidelines, PV Agreements)
• Maintains oversight of the department archive of safety documents, including relevant communications and other key documents
• Assists in operational support of safety related documents including development of aggregate reports (DSUR, US PADER, PSUR/PBRER) and signal management case processing compliance
• Ensures all Other Manufacturer Letters (OMLs) are reported to the appropriate manufacturer for all studies (and any potential future) post-marketing requirements
• Oversees various operational activities (e.g., Query resolution, Reconciliation, IDMC, MedDRA/WHODD versioning, RSI Tracking, Investigator Meetings and Site Initiation Visits, CDA/NDA, TMF filing) solving issues and discrepancies
• Aids in product filing activities
• Manages budget/contract review process, serving as administrator, negotiator, QC
• Collaborates with corporate partners to ensure proper exchange of drug-safety data, developing associated Plans and PV contracts as an individual contributor, leading a critical function of internal and external stakeholders
• Provides PV operational guidance and support for interdepartmental and/or corporate initiatives
• Contributes to establishing and maintaining global post-marketing capabilities, including and not limited to PV system, key partnerships and procedures, EU-QPPV/PSMF, Local QPs partnership, training, compliance, and metrics/KPIs to ensure robust quality PV System
• Actively participates in PV leadership in assigned activities and daily activities with excellent interpersonal, organizational, and communication skills
• Any additional responsibilities not noted above and in line with PV operations/compliance support

Preferred Qualifications

Experience of Oracle Argus Safety is preferred