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Pharmacovigilance Strategy Manager
Bionical Emas. Lead the development, implementation, and ongoing evolution of pharmacovigilance strategies for Early Access Programs, Post Trial Access, and Real-World Data Collection .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in pharmacovigilance strategies, frameworks, and compliance within global pharmaceutical and life sciences environments, with a focus on Early Access Programs and safety management. Proven ability to build relationships with stakeholders and manage vendor oversight while ensuring regulatory adherence.
Highest-signal resume keywords
Pharmacovigilance ExperienceRegulatory ComplianceVendor ManagementSafety ReportingCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Pharmacovigilance Framework DevelopmentSafety Management PlansAggregate Safety ReportingQuality Systems ManagementRegulatory Requirements Assessment
Soft Skills
Strategic GuidanceRelationship BuildingInfluencing SkillsChange Management
Industry Keywords
Early Access ProgramsPost Trial AccessReal-World Data CollectionManaged AccessCompassionate Use
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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