Pharmacovigilance Strategy Manager

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🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧐 Strategy

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Bionical Emas

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1998

🏥 Healthcare

📦 Logistics

💊 Pharmaceuticals

Healthcare • Logistics • Pharmaceuticals

Bionical Emas is a B2B life sciences services company that provides clinical development and pharmaceutical support, including clinical trial supply, regulatory affairs, pharmacovigilance, medical affairs, quality assurance, and distribution/logistics. The company appears to support pharmaceutical and biotech organizations with trial management, patient access, and related operational services, and recruits professionals across these functions.

📋 Description

• Lead the development, implementation, and ongoing evolution of pharmacovigilance strategies for Early Access Programs, Post Trial Access, and Real-World Data Collection • Design and implement scalable pharmacovigilance oversight models aligned with programme objectives, client expectations, and global regulatory requirements • Contribute to new pharmacovigilance service offerings for Early Access • Provide strategic guidance on safety reporting obligations, governance frameworks, and country-specific requirements • Monitor the global access environment and translate regulatory developments into practical programme strategies • Assess pharmacovigilance requirements for geographic expansion, new access routes, and changing patient populations • Manage safety-related change while maintaining compliance with minimal disruption • Oversee programme close-out planning, final assessments, reconciliation, document retention, vendor offboarding, lessons learned, and improvement actions • Partner with Business Development to design tailored pharmacovigilance solutions and support proposals • Act as the primary strategic pharmacovigilance contact and trusted advisor for assigned client accounts • Build relationships with internal teams, clients, vendors, regulators, ethics committees/IRBs, and programme partners • Influence cross-functional groups including Project Management, Patient Access, Quality, Regulatory, Medical Affairs, Commercial, Legal, and others • Establish vendor oversight frameworks, communication pathways, performance expectations, and escalation processes • Monitor vendor compliance, quality metrics, deviations, CAPAs, and audit outcomes • Oversee programme-level pharmacovigilance compliance, systems, agreements, documentation, and traceability • Identify and mitigate safety, process, and quality risks • Support inspection readiness and regulatory authority interactions • Define country- and programme-specific strategies for individual and aggregate safety reporting • Oversee preparation, review, and submission of aggregate and periodic reports, line listings, and safety summaries • Provide strategic oversight of programme implementation and ongoing safety management • Develop Safety Management Plans, Pharmacovigilance Agreements, and scalable governance, quality, and procedural frameworks

🎯 Requirements

• A bachelors or similar degree within the life sciences would be advantageous • Extensive pharmacovigilance experience within a global pharmaceutical, biotechnology, or life sciences environment • Experience supporting Early Access, Managed Access, Compassionate Use, Named Patient, or similar patient access programmes • Proven ability to develop and implement pharmacovigilance frameworks across multiple regions in line with regulatory, reporting, and compliance requirements • Experience acting as a senior pharmacovigilance representative for clients, programmes, or strategic initiatives • Experience contributing strategic expertise to commercial or business development activities • Experience managing vendors, inspections, audits, quality systems, and cross-functional stakeholder relationships

🏖️ Benefits

• 25 days of vacation • Vacation days purchasing scheme • 1 extra vacation day per each 3 years of service • Discretionary Annual Bonus • Sabbatical of 3 to 6 months (after 2 years of service) • Free food and beverages at all offices • Life Insurance • Health Insurance and Employee Assistance Programme • Employee Support Networks • Flexible and hybrid work • Opportunities for career development and skills development • Welcoming, flexible, and supportive culture • Work-life balance • Accessibility accommodations for applicants with disabilities

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