Position Overview

We are seeking a highly motivated and experienced Senior Pharmacovigilance Manager to join our dynamic team. This role is crucial in ensuring the safety and compliance of our pharmacovigilance operations.

Key Responsibilities

• Leadership & Team Management:
• Lead, mentor, and develop the pharmacovigilance team to ensure high performance and professional growth.
• Manage team workload, allocate resources, and monitor team performance to achieve department goals and KPIs.
• Pharmacovigilance Operations:
• Oversee case processing activities, ensuring compliance with regulatory requirements and internal SOPs.
• Monitor and manage adverse event reporting and safety data exchange agreements.
• Coordinate signal detection, risk management plans (RMPs), and aggregate safety reports.
• Compliance & Quality Oversight:
• Ensure PV operations adhere to global regulatory requirements (e.g., FDA, EMA, MHRA).
• Lead internal and external audits, and implement corrective and preventive action (CAPA) plans.
• Collaboration & Stakeholder Management:
• Act as the primary point of contact for clients, regulatory authorities, and internal stakeholders regarding pharmacovigilance matters.
• Collaborate with cross-functional teams including clinical operations, medical affairs, and regulatory departments.
• Process Improvement:
• Drive continuous improvement initiatives within PV processes and systems.
• Stay updated with industry trends, best practices, and changes in pharmacovigilance regulations.

Qualifications & Requirements

• Education: Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field. Advanced degree (e.g., MSc, PharmD, or PhD) preferred.
• Experience:
• Minimum 6+ years of experience in pharmacovigilance operations, with a track record of increasing responsibility.
• Proven experience in team management or leadership roles.
• Strong preference for candidates with a background in CROs or pharmaceutical companies.
• Skills:
• In-depth understanding of global PV regulations and guidelines (e.g., ICH, GVP, FDA, EMA).
• Excellent project management, organizational, and analytical skills.
• Proficiency in safety databases and PV tools.
• Strong communication and interpersonal skills with a collaborative mindset.

What We Offer

• Competitive salary and benefits package.
• Opportunity to work in a collaborative and innovative environment.
• Professional development and career growth opportunities.