Coordinator – Pharmacovigilance (PV Workflow & Safety Operations)
Location: India
Work Model: Remote / Work From Home (India-Based)
Employment Type: Permanent Contract
Department: Life Cycle – Safety and Vigilance
Experience Required: 3–4 Years in Pharmacovigilance Workflow Case Management
Role Overview
The Coordinator – Pharmacovigilance is responsible for monitoring, optimizing, and coordinating pharmacovigilance (PV) workflow systems to ensure timely case processing, regulatory compliance, and operational efficiency. This role plays a critical function in drug safety operations by managing workflow allocation, supporting case management activities, and ensuring adherence to global pharmacovigilance regulations including GVP and FDA guidelines.
This opportunity is ideal for experienced pharmacovigilance professionals seeking remote PV operations roles in global drug safety, adverse event reporting, and regulatory compliance management.
Key Responsibilities
Monitor real-time pharmacovigilance workflow systems to optimize resource allocation and operational efficiency.
Track case progress to ensure timely processing, submission, and compliance with regulatory timelines.
Assign safety cases and related tasks to appropriate teams based on workload and expertise.
Collaborate with cross-functional stakeholders including development, safety, regulatory, and operations teams.
Provide technical guidance and cross-training to team members on workflow tools and PV processes.
Investigate workflow bottlenecks and resolve operational issues within strict deadlines.
Analyze performance metrics and recommend improvements to enhance case processing efficiency.
Support documentation of PV processes and ensure alignment with internal SOPs and global regulatory standards.
Required Qualifications
Bachelor’s Degree or higher in Life Sciences, Pharmacy, Biotechnology, or related discipline.
3–4 years of experience in Pharmacovigilance workflow case management within pharmaceutical or cosmetic safety environments.
Strong understanding of Global Pharmacovigilance Practices (GVP), FDA regulations, and cosmetic safety requirements.
In-depth knowledge of adverse event reporting, causality assessment, and safety database processes.
Experience reading and interpreting Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs).
Proficiency in Microsoft Office applications.
Technical and Functional Skills
Strong knowledge of pharmacovigilance principles and global drug safety regulations.
Experience working with safety databases and workflow management systems.
Analytical skills to evaluate performance metrics and identify workflow improvements.
Project coordination and task prioritization capabilities.
Ability to document processes clearly and maintain audit readiness.
Behavioral Competencies
Strong organizational and time management skills.
Accountability and decision-making ability.
Adaptability in dynamic regulatory environments.
Team collaboration and cross-functional communication.
Emotional intelligence and reliability under deadline-driven conditions.
Career Opportunity
This Pharmacovigilance Coordinator role offers the opportunity to contribute to global drug safety operations, regulatory compliance management, and PV workflow optimization within a remote working environment. Professionals with experience in adverse event case processing, regulatory reporting, and safety agreements will find strong alignment with this position.
Job Category:
Pharmacovigilance and Drug Safety
Regulatory Affairs and Compliance
Clinical Safety Operations
Life Sciences Operations
Remote Pharma Jobs India
This position is ideal for mid-level pharmacovigilance professionals seeking long-term growth in safety operations, regulatory-compliant case management, and global PV workflow coordination within the pharmaceutical and cosmetic safety sectors.
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