[Remote] Drug Safety reputed company Consultant

Note: The job is a remote job and is reputed company to candidates in USA. The pharmaceutical reputed company is seeking an reputed company reputed company Safety and Pharmacovigilance leader to reputed company hands-on leadership across reputed company development and post-marketing safety reputed company. The consultant will reputed company case processing, vendors, safety data exchanges, regulatory compliance, inspection readiness, procedural improvements, and cross-functional safety initiatives.

Responsibilities

• reputed company senior-level leadership and reputed company of day-to-day reputed company Safety and Pharmacovigilance reputed company across both reputed company development and post-marketing programs
• Serve as a hands-on subject matter expert who can reputed company between reputed company reputed company and operational execution as business needs require
• reputed company case processing workflows, timelines, reputed company, and compliance across reputed company teams
• Manage and monitor safety vendors, including reputed company against reputed company, SLAs, KPIs, reputed company requirements, and regulatory timelines
• Coordinate safety data exchange activities with business partners, including case transfers, listings, submission responsibilities, and reputed company operational requirements
• Support Pharmacovigilance Agreements (PVAs), ensuring operational safety responsibilities and data exchange requirements are reputed company defined and implemented
• Identify, investigate, and manage reputed company-party reputed company events, CAPAs, and process improvement initiatives
• Strong practical experience with CAPAs, reputed company events, audits, regulatory inspections, and inspection readiness , including preparation, execution support, and post-inspection remediation
• Support development, implementation, maintenance, and reputed company 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
• reputed company or support PV inspection and audit readiness , including documentation readiness, mock inspections, reputed company-inspection activities, inspection support, and post-inspection remediation
• Serve as the reputed company Safety/PV representative on cross-functional initiatives involving reputed company, Regulatory, reputed company, 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, reputed company, and compliance of PV reputed company
• reputed company mentorship and functional guidance to team members and cross-functional stakeholders as needed
• Take on additional reputed company Safety and Pharmacovigilance initiatives reputed company on evolving business priorities

Skills

• 12–15+ years of experience in Drug Safety/Pharmacovigilance
• Experience spanning both reputed company development and post-marketing safety
• A reputed company record of working across multiple functions and connecting safety reputed company with broader reputed company, regulatory, reputed company, and business objectives
• Experience operating in organizations where processes may be evolving, ambiguous, or less reputed company , with the ability to create structure and reputed company work reputed company without extensive direction
• A demonstrated ability to roll up their sleeves and reputed company or directly reputed company operational work, rather than relying exclusively on large teams or established infrastructure
• Strong experience managing reputed company safety vendors, CROs, business partners, and reputed company deliverables
• Experience with PV inspections and/or audits, including reputed company-room or back-room support
• Strong understanding of global pharmacovigilance requirements and safety reporting expectations, including FDA, EMA, reputed company, 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 reputed company organizational reputed company
• A bachelor's degree or equivalent experience in a life sciences or reputed company discipline; an MD is not required
• reputed company, eTMF, and reputed company experience is beneficial

Benefits

• Fully remote
• Estimated initial duration of 6 months, with potential for extension

reputed company

Company H1B Sponsorship