Safety Operations Consultant

Redbock - an NES Fircroft company; United States; On-site; USD 180,000 - 230,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking a Director-level Safety Operations Consultant to provide hands-on leadership across clinical and post-marketing safety. The role calls for an experienced PV leader who thrives in dynamic, less-structured environments and can balance strategic oversight with operational execution.

You will collaborate across cross-functional teams to ensure safety operations, regulatory compliance, inspection readiness, and continuous process improvement, while guiding

Qualifications

• 12–15+ years in Drug Safety/Pharmacovigilance.
• Experience in clinical development and post‑marketing safety.
• Ability to operate in evolving, ambiguous environments.
• Hands-on execution with ability to mentor teams.
• Experience managing external safety vendors and CROs.
• PV inspections and audits experience.
• Knowledge of FDA, EMA, MHRA, ICH requirements.
• Argus PV system experience required.
• Strong written and verbal communication.
• Bachelor's in life sciences; MD not required.

Responsibilities

• Provide senior leadership of day-to-day patient safety operations.
• Balance strategic oversight with operational execution.
• Oversee case processing, timelines, quality, and compliance.
• Manage safety vendors and monitor KPIs.
• Coordinate safety data exchange with partners.
• Support PVAs and data exchange requirements.
• Identify and manage CAPAs and quality events.
• Lead PV inspections and audit readiness.
• Develop and improve PV SOPs and work instructions.
• Mentor team members and cross-functional stakeholders.
• Support product launches and evolving vendor relationships.

Skills

PV leadership

Cross-functional leadership

Vendor management

CAPAs

Audits & inspections

Process improvement

Regulatory knowledge

Communication

Mentorship

Strategic thinking

Education

Bachelor's degree in Life Sciences

Tools

Argus PV

Veeva

eTMF

EDC

Job description

Our pharmaceutical client is seeking a Director-level Safety Operations Consultant to provide hands-on leadership across clinical and post-marketing safety operations.

This is an opportunity for an experienced PV leader who can operate effectively in a dynamic, fast-moving, and less structured environment. The ideal consultant will bring strong strategic and cross-functional leadership experience while also being comfortable getting into the operational details when needed.

The consultant will work closely with cross-functional teams to ensure effective safety operations, regulatory compliance, inspection readiness, and continuous process improvement.

Key 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.

Ideal Background

• 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. Veeva, eTMF, and EDC experience is beneficial.
• 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