Pharmacovigilance Strategy Manager

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Spearhead the development, execution, and continuous enhancement of pharmacovigilance strategies for Early Access Programs, Post Trial Access, and Real-World Data Collection.

• Design and implement scalable pharmacovigilance oversight models that align with program objectives, client expectations, and global regulatory standards.

• Contribute to the creation of new pharmacovigilance service offerings for Early Access.

• Provide strategic insights on safety reporting obligations, governance frameworks, and country-specific requirements.

• Monitor the global access landscape and convert regulatory changes into actionable program strategies.

• Evaluate pharmacovigilance needs for geographic expansion, new access methods, and evolving patient demographics.

• Manage safety-related changes while ensuring compliance with minimal disruption.

• Oversee program close-out planning, final assessments, reconciliation, document retention, vendor offboarding, lessons learned, and improvement initiatives.

• Collaborate with Business Development to create customized pharmacovigilance solutions and support proposals.

• Serve as the main strategic pharmacovigilance contact and trusted advisor for designated client accounts.

• Foster relationships with internal teams, clients, vendors, regulators, ethics committees/IRBs, and program partners.

• Influence cross-functional teams, including Project Management, Patient Access, Quality, Regulatory, Medical Affairs, Commercial, Legal, and others.

• Establish frameworks for vendor oversight, communication pathways, performance expectations, and escalation processes.

• Monitor vendor compliance, quality metrics, deviations, CAPAs, and audit results.

• Oversee pharmacovigilance compliance at the program level, including systems, agreements, documentation, and traceability.

• Identify and mitigate risks related to safety, processes, and quality.

• Support inspection readiness and interactions with regulatory authorities.

• Define strategies specific to countries and programs for individual and aggregate safety reporting.

• Supervise the preparation, review, and submission of aggregate and periodic reports, line listings, and safety summaries.

• Provide strategic oversight for program implementation and ongoing safety management.

• Develop Safety Management Plans, Pharmacovigilance Agreements, and scalable governance, quality, and procedural frameworks.

⛳️ Requirements

• A bachelor's degree or equivalent in the life sciences is preferred.

• Significant pharmacovigilance experience in a global pharmaceutical, biotechnology, or life sciences context.

• Experience supporting Early Access, Managed Access, Compassionate Use, Named Patient, or similar patient access programs.

• Demonstrated capability to develop and implement pharmacovigilance frameworks across various regions in alignment with regulatory, reporting, and compliance standards.

• Experience serving as a senior pharmacovigilance representative for clients, programs, or strategic initiatives.

• Proven experience contributing strategic expertise to commercial or business development efforts.

• Experience managing vendors, inspections, audits, quality systems, and cross-functional stakeholder relationships.

🏝️ Benefits

• 25 days of vacation.

• Vacation days purchasing scheme.

• 1 additional vacation day for every 3 years of service.

• Discretionary Annual Bonus.

• Sabbatical of 3 to 6 months after 2 years of service.

• Free food and beverages at all office locations.

• Life Insurance.

• Health Insurance and Employee Assistance Programme.

• Employee Support Networks.

• Flexible and hybrid working arrangements.

• Opportunities for career and skills development.

• A welcoming, flexible, and supportive culture.

• Work-life balance.

• Accessibility accommodations for applicants with disabilities.