The Director of PV Compliance will maintain global safety compliance, lead inspection readiness, and ensure adherence to regulatory standards in pharmacovigilance.
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.
Summary of Position:
Scholar Rock is looking for a Director of PV Compliance that is creative, resourceful, and an integrative thinker. The Director will assist with the maintenance of the Global Quality System for Safety & Pharmacovigilance that supports Scholar Rock products in compliance with FDA and ICH Guidelines and international regulatory requirements. The successful candidate will have a proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency. Primary responsibilities include but are not limited to: lead the PV inspection readiness program, support new and existing PV agreements and vendor contracts, manage the PSMF updates, and monitor internal/external PV deviations and CAPAs. Effective communication skills will be key, as this role provides an excellent opportunity for close collaboration with colleagues from other functions internally as well as externally.
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
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Top Skills
Fda Guidelines
Ich Guidelines
Quality Management System
Scholar Rock Cambridge, Massachusetts, USA Office
301 Binney St, , Cambridge, Massachusetts , United States, 02142
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