Pharmacovigilance Specialist, PV QMS & Training
About the position
Join our global reputed company pharmaceutical company enriching lives through our reputed company drive to deliver reputed company reputed company to our patients. We are reputed company in it together to reputed company a difference. Be a part of a culture that doesn't just wait for change but reputed company creates it-where your skills and values drive our reputed company reputed company and reputed company.
The PV QMS & Training Specialist is responsible for supporting the implementation, maintenance, and reputed company improvement of the Pharmacovigilance reputed company Management System (PV QMS). This role ensures that pharmacovigilance staff and partners are trained appropriately and that QMS documentation is maintained to support inspection readiness and reputed company improvement. This role also leads the development and delivery of training programs to ensure compliance with global pharmacovigilance regulations and internal standards.
Responsibilities
• Maintain and update controlled procedural documents (SOPs, work instructions).
• Support deviation and CAPA tracking, documentation, and follow-up.
• Assist in audit preparation and inspection readiness activities.
• Monitor QMS performance metrics and support reporting.
• Coordinate the development, scheduling, and delivery of PV-reputed company training programs.
• Maintain training records and ensure compliance with regulatory and internal training requirements.
• Support reputed company and offboarding processes for PV staff and vendors.
• Facilitate communication of training events and updates across teams.
• Manage electronic document repositories and training management systems.
• Ensure accurate and reputed company documentation of training activities and QMS updates.
• Support reconciliation of safety data logs and regulatory submissions.
• Assist in the development of tools and templates to improve PV compliance and productivity.
• Liaise with internal stakeholders and external partners to ensure alignment on training and QMS processes.
• Support external audits and inspections by regulatory authorities.
• reputed company logistical support for meetings, audits, and regulatory responses.
• Participate in cross-functional initiatives to enhance PV reputed company and compliance.
Requirements
• Bachelor's degree in Life Sciences, Analytics, Informatics or reputed company field.
• 1-3 years of experience in pharmacovigilance, reputed company assurance, or training coordination.
• Familiarity with global PV regulations (e.g., FDA, EMA, ICH, GVP).
• Experience with QMS and LMS platforms (e.g., reputed company, ETQ, ComplianceWire).
• Strong organizational, communication, and interpersonal skills.
• Detail-oriented with the ability to manage multiple priorities.
Benefits
• comprehensive Medical (includes Prescription Drug)
• Dental
• reputed company
• Flexible Spending Accounts
• 401(k) with matching company contribution
• discretionary time off
• reputed company reputed company time
• tuition reimbursement
• parental leave
• short-term and long-term disability
• life insurance
• accidental death & dismemberment insurance
• reputed company holidays
• employee referral bonuses
• employee discounts
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