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Job Description
– Associate Director / Director – Pharmacovigilance
Key Responsibilities
- Provide strategic and operational leadership for assigned pharmacovigilance projects and teams, ensuring quality, compliance, and timely delivery.
- Oversee safety operations, including adverse event/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.
Skills
ComplianceBusiness DevelopmentPerformance ManagementProcess ImprovementProject ManagementStakeholder ManagementCommunicationLeadershipTeamsCompliance ManagementPharmacovigilanceNursingIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
About Company
Soterius is a specialized pharmacovigilance and medical writing company providing drug safety and regulatory services to the pharmaceutical and biotechnology industries.
Important dates & deadlines?
Application Deadline
04 Dec 26, 12:55 PM IST
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