Job Title: Analyst, GCM Vigilance Reporting
Location: Chennai
Summary:
Are you a science or pharmacy graduate with a passion for patient safety and regulatory compliance? We are seeking a detail-oriented and analytical Analyst to join our Global Complaint Management (GCM) Vigilance Reporting team in Chennai. In this role, you will be responsible for managing global complaints and vigilance reporting for pharmaceutical or medical device products, ensuring adherence to regulatory requirements and contributing to the overall safety of our products. This is an excellent opportunity to build a strong career in vigilance reporting, pharmacovigilance, or medical device complaint handling within a global, compliance-driven environment.
About the Role:
As an Analyst, GCM Vigilance Reporting, you will play a critical role in ensuring the safety and compliance of our products. You will be responsible for managing global complaints and vigilance reporting for pharmaceutical or medical device products, directly supporting regulatory compliance, patient safety, and the timely submission of reportable events to regulatory authorities such as the FDA and regional competent authorities. This role requires a strong understanding of medical terminology, regulatory guidelines, and the ability to analyze complex data to make informed decisions.
Key Responsibilities:
- Complaint Triage and Evaluation: Perform complaint triage, meticulously evaluating cases from a patient safety perspective to determine the potential impact and severity of the event.
- Regulatory Reporting Decisions: Make informed global regulatory reporting decisions based on applicable standards, ensuring accurate and compliant reporting to relevant authorities.
- Regulatory Report Creation and Submission: Prepare and submit regulatory reports to authorities (e.g., FDA, EU Competent Authorities) in a timely and accurate manner, adhering to specific reporting requirements.
- Complaint Lifecycle Management: Manage complaints throughout their entire lifecycle, from initial registration and thorough investigation to final closure, ensuring all steps are completed efficiently and effectively.
- Data Collection, Assessment, and Interpretation: Collect, assess, and interpret complaint and adverse event information to identify trends, patterns, and potential safety signals.
- Follow-up and Case Updates: Coordinate follow-ups for incomplete case data, proactively seeking missing information and ensuring timely updates to case records.
- Customer Advocacy Escalation: Escalate customer advocacy issues when necessary, supporting the resolution process to ensure customer satisfaction and product safety.
- Communication and Collaboration: Communicate effectively with internal teams (e.g., Quality Assurance, Regulatory Affairs) and external stakeholders (e.g., regulatory agencies) to share information, address concerns, and ensure alignment.
Required Skills & Knowledge:
- Strong understanding of medical terminology, clinical product usage, and patient safety concepts.
- Proven ability to analyze safety data, risk signals, and complaint information to identify potential safety concerns.
- Excellent written and verbal communication skills, with the ability to clearly and concisely communicate complex information to regulatory bodies and internal stakeholders.
- Knowledge of FDA, EU MDR, vigilance reporting processes, ICSR handling, and QMS environments is preferred.
- Proficiency in data management and analysis tools.
- Ability to work independently and as part of a team.
Education & Experience:
- Required: Graduate in Science, Medical Engineering, or Allied Sciences.
- Preferred:
- B.Sc Nursing, Pharmacy, Biomedical Engineering, Medical Technology, or Clinical Laboratory Science.
- Experience in healthcare, quality assurance, medical devices, or regulatory reporting.
Benefits of Joining Our Team:
- Hybrid Working Model: Enjoy the flexibility of a hybrid working model, balancing work-from-home and in-office collaboration.
- Global Exposure: Gain valuable exposure to global regulatory and vigilance frameworks, expanding your knowledge and expertise in the field.
- Career Growth Opportunities: Benefit from opportunities for career growth in Quality, Regulatory Affairs, and Pharmacovigilance, with potential for advancement within the organization.
- Compliance-Driven Environment: Work in a compliance-driven, FDA-regulated environment, ensuring adherence to the highest standards of quality and safety.
- Competitive Compensation and Benefits: Receive a competitive salary and comprehensive benefits package.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.