Quality and Training Specialist – Pharmacovigilance

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

📋 Description

• Ensure that PV project teams possess the necessary skills and receive quality oversight.

• Create and implement training programs tailored for PV project teams.

• Perform real-time quality assessments of project deliverables.

• Keep SOPs, work instructions, and client procedural documents current and accurate.

• Assist in the development and reporting of PV compliance metrics.

• Lead initiatives for escalation and cross-functional process improvements regarding GPV quality issues.

• Guarantee preparedness for PV audits and inspections.

• Act as the main point of contact for all PV-related quality assurance concerns.

• Present trends in quality and provide recommendations to stakeholders.

• Mentor and train peers while collaborating with cross-functional teams, CROs, and vendors.

⛳️ Requirements

• A Bachelor’s or Master’s degree in Pharmacy or Life Sciences is required.

• A minimum of 7 years of relevant experience in Pharmacovigilance (PV).

• At least 5 years in PV quality roles that support audits, inspections, and GPV compliance activities.

• Comprehensive knowledge of global GPV regulations (FDA, ICH, CDSCO-PvPI, EU GVP; PMDA is a plus).

• Proficiency in handling audits/inspections and developing appropriate responses.

• Advanced understanding of Quality Management Systems (QMS), process improvement, and quality governance.

• Capability to manage complex projects and spearhead training initiatives.

• Familiarity with electronic systems utilized in regulated environments (drug safety, LMS, documentation management).

🏝️ Benefits

• Reasonable accommodations available for individuals with disabilities.

• We are an Equal Opportunity Employer.

• Opportunities for professional development.