Note: The job is a remote job and is open to candidates in USA. Redbock, an NES Fircroft company, is seeking a Director-level Safety Operations Consultant to provide hands-on leadership across clinical development and post-marketing pharmacovigilance operations. The role oversees case processing, safety vendors, regulatory compliance, inspection readiness, safety data exchange, procedural documentation, and continuous process improvement while partnering with cross-functional teams.
Responsibilities
- Provide senior-level leadership and oversight of day-to-day Patient Safety and Pharmacovigilance operations across both clinical development and post-marketing programs
- Serve as a hands-on subject matter expert who can move between strategic oversight and operational execution as business needs require
- Oversee case processing workflows, timelines, quality, and compliance across internal and external teams
- Manage and monitor safety vendors, including performance against contracts, SLAs, KPIs, quality requirements, and regulatory timelines
- Coordinate safety data exchange activities with business partners, including case transfers, listings, submission responsibilities, and related operational requirements
- Support Pharmacovigilance Agreements (PVAs), ensuring operational safety responsibilities and data exchange requirements are clearly defined and implemented
- Identify, investigate, and manage third-party quality events, CAPAs, and process improvement initiatives
- Strong practical experience with CAPAs, quality events, audits, regulatory inspections, and inspection readiness , including preparation, execution support, and post-inspection remediation
- Support development, implementation, maintenance, and continuous improvement of SOPs, work instructions, and other PV procedural documentation
- Maintain appropriate study blinding and support unblinding activities in accordance with applicable SOPs and study requirements
- Lead or support PV inspection and audit readiness , including documentation readiness, mock inspections, pre-inspection activities, inspection support, and post-inspection remediation
- Serve as the Patient Safety/PV representative on cross-functional initiatives involving Clinical, Regulatory, Quality, IT, Medical Affairs, and other functions
- Support safety operational activities associated with product launches, new business partnerships, and evolving vendor relationships
- Evaluate operational impacts of new or changing global PV regulations and translate requirements into practical processes
- Identify opportunities to improve the efficiency, scalability, quality, and compliance of PV operations
- Provide mentorship and functional guidance to team members and cross-functional stakeholders as needed
- Take on additional Patient Safety and Pharmacovigilance initiatives based on evolving business priorities
Skills
- 12–15+ years of experience in Drug Safety/Pharmacovigilance
- Experience spanning both clinical development and post-marketing safety
- A track record of working across multiple functions and connecting safety operations with broader clinical, regulatory, quality, and business objectives
- Experience operating in organizations where processes may be evolving, ambiguous, or less structured , with the ability to create structure and move work forward without extensive direction
- A demonstrated ability to roll up their sleeves and perform or directly oversee operational work, rather than relying exclusively on large teams or established infrastructure
- Strong experience managing external safety vendors, CROs, business partners, and related deliverables
- Experience with PV inspections and/or audits, including front-room or back-room support
- Strong understanding of global pharmacovigilance requirements and safety reporting expectations, including FDA, EMA, MHRA, and ICH requirements
- Experience with safety databases and PV systems, with Argus experience required
- Strong written and verbal communication skills and the ability to work effectively with stakeholders at all organizational levels
- A bachelor's degree or equivalent experience in a life sciences or related discipline; an MD is not required
- Veeva, eTMF, and EDC experience is beneficial
Benefits
- Fully remote work arrangement
Company Overview
Company H1B Sponsorship