About the role
Key Responsibilities
- Provide strategic and operational leadership for assigned pharmacovigilance projects and teams, ensuring quality, compliance, and timely delivery.
- Oversee safety operations, including ICSR case processing for clinical trials and post-marketing activities, in accordance with applicable regulations, SOPs, and client requirements.
- Ensure compliance with global pharmacovigilance regulations, quality standards, contractual commitments, and internal processes.
- Lead and mentor teams, including resource planning, performance management, training, and capability development.
- Act as a senior point of contact for internal and external stakeholders and effectively manage client relationships.
- Drive continuous improvement, process optimization, standardization, and operational efficiency across assigned functions.
- Provide leadership and representation during client audits, internal audits, and regulatory inspections; oversee responses and CAPA implementation.
- Monitor quality and operational metrics, identify risks/issues, and ensure timely escalation and resolution.
- Review and approve relevant SOPs, work instructions, reports, and other functional documentation.
- Support strategic initiatives, new project implementations, business development activities, and other organizational priorities.
Required Skills & Experience
- Strong knowledge of pharmacovigilance, drug safety, and global regulatory requirements.
- Significant experience in pharmacovigilance/safety operations, quality, or a related pharmaceutical/healthcare environment.
- Proven experience in people leadership, project management, client/stakeholder management, and audit/inspection support.
- Strong leadership, communication, analytical, decision-making, and problem-solving skills.
- Ability to work independently, manage multiple priorities, and operate effectively in a global/matrix environment.
- Experience in process improvement and quality/compliance management.
Educational Requirements
- Bachelor's/Postgraduate degree or equivalent in Pharmacy, Life Sciences, Medicine, Nursing, Biotechnology, or another relevant scientific/healthcare discipline.
- Associate Director: Typically, 10+ years of relevant experience.
- Director: Typically, 12–15+ years of relevant experience, with significant leadership and strategic responsibilities.