Director, PV Compliance

Position Responsibilities:

• Monitor activities of the safety vendor to ensure adherence and compliance with applicable SMPs, KPIs/Metrics, SDEAs and other contractual agreements and for compliance trends
• Manage internal and vendor deviations and CAPAs in collaboration with Scholar Rock QA and the safety vendor
• Actively monitor internal PV and safety vendor deviations to ensure accuracy of the root cause, applicable corrective actions and timelines
• Collaborate with Scholar Rock QA to develop a set of procedures for documentation of PV compliance and quality assurance plans to improve or maintain PV data quality
• Assist Scholar Rock QA in reviewing, updating and finalizing the safety vendor Quality Agreement
• Manage the quarterly PSMF updates
• Actively support and collaborate with cross-functional teams during company-wide inspection readiness activities
• Lead the development of an inspection readiness program for pharmacovigilance
• Support internal PV audits, Health Authority Inspections, and safety vendor audits, as appropriate
• Act as the Subject Matter Expert (SME) for PV compliance related activities during audits and inspections
• Assist with audit responses from Pharmacovigilance and vendors and evaluate proposed corrective actions and/or preventative actions for compliance with applicable regulations, guidelines, and Scholar Rock policies.
• Ensure new PV personnel are assigned appropriate training as defined by their manager
• Maintain the internal PV and safety vendor Training Curricula
• Identify relevant quality-related training needs and conducts training as required
• Monitor internal PV and safety vendor training compliance monthly and escalates late training as needed
• Assign safety vendor training in collaboration with QA Training
• Actively support PV personnel and SMEs with the development and revision of PV policies, SOPs and procedures that support the Scholar Rock Quality System
• Responsible for managing procedures though the Quality Management System
• Collaborate with Scholar Rock business owners and legal to ensure contracts with external vendors contain the appropriate safety language to ensure complete and timely reporting of safety information to PV
• Negotiate with internal and external stakeholders as needed to ensure the external vendor template is aligned with Scholar Rock standards
• Participate in the management of the Scholar Rock PV language template

Candidate Requirements:

• BS or MS degree or equivalent professional qualification in a health science field (e.g., nursing or pharmacy) with working knowledge in a relevant scientific/technical discipline with demonstrated experience in the responsibilities, deliverables, and skills
• At least 7 years of PV compliance experience within the pharmaceutical, biotech or CRO industry
• Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Safety department
• Thorough knowledge and experience with quality systems
• Excellent oral and written communication skills
• Strong interpersonal and leadership skills and demonstrated ability to manage, motivate and influence work behaviors of individuals who are not direct reports
• Comprehensive knowledge of the international pharmacovigilance regulations and requirements, including the Food and Drug Administration (FDA), European Medicines Agency (EMA), and Good Pharmacovigilance Practices (GVP)
• Excellent problem solving and analysis skills
• Strong ability to see trends and convert information to insights
• Ability to adapt precedent and develop creative and effective solutions to solve problems
• Demonstrable Patient Safety and/or Clinical/ Drug/Biologic Development experience across a range of activities