Director/Sr Director of Pharmacovigilance Operations - Remote

Overview

The Director/Sr Director of Pharmacovigilance (PV) Operations is the lead point of contact and accountable for PV Operations, responsible for directing the day-to-day activities including planning, oversight and management of vendors, business partners, contracting for Individual Case Safety Report (ICSR) activity, to ensure efficiency, quality, and compliance with internal procedures and global regulations.

In Short

• Lead point of contact for PV Operations.
• Direct day-to-day activities including planning and oversight.
• Manage vendors and business partners.
• Contract for Individual Case Safety Report (ICSR) activity.
• Ensure compliance with internal procedures and global regulations.
• Oversee study start up, conduct, and close-out.
• Manage operational budget of PV vendors and systems.
• Compile metrics and support department meetings.
• Collaborate on risk management and PV activities.
• Lead safety vendor planning and process improvements.

Requirements

• Experience in Pharmacovigilance operations.
• Strong understanding of ICSR and compliance regulations.
• Proven vendor management skills.
• Ability to oversee operational budgets.
• Experience in risk management.
• Strong leadership and collaboration skills.
• Excellent communication skills.
• Ability to implement process improvements.
• Experience in clinical trials is a plus.
• Advanced degree in life sciences or related field preferred.

Benefits

• Competitive salary and benefits package.
• Opportunity to work on innovative therapies.
• Collaborative work environment.
• Professional development opportunities.
• Contribute to meaningful patient outcomes.