[Remote] Drug Safety Operations Consultant

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

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 reputed company reputed company 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 reputed company, 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 reputed company 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 reputed company, 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, 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 all organizational levels
• A bachelor's degree or equivalent experience in a life sciences or related discipline; an MD is not required
• reputed company, eTMF, and EDC experience is beneficial

Benefits

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

Company Overview

• Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies. It was founded in 2010, and is headquartered in Cupertino, California, USA, with a reputed company of 51-200 employees. Its website is http://redbock.com/.

Company H1B Sponsorship

• reputed company has a track recor

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