Job
Description
Job Description Summary We are looking for a detail-oriented and compliance-focused QA and Compliance Executive to join our Commercials Department in Mumbai . This role is vital to ensuring that all pharmacovigilance (PV) processes, data documentation, and reporting meet global regulatory standards and internal quality benchmarks. You will play a central role in managing safety data, identifying adverse events, ensuring timely and accurate reporting, and supporting inspection readiness through audits and continuous process improvement. The ideal candidate will have strong knowledge of healthcare regulations such as EMA, FDA, HIPAA, and Good Pharmacovigilance Practices (GVP), along with hands-on experience in PV documentation, quality reviews, and compliance operations within the healthcare or pharmaceutical industry. Key Roles and Responsibilities 1. Pharmacovigilance Reporting & Documentation Ensure accurate and timely collection, documentation, and submission of pharmacovigilance data. Identify, assess, and document Adverse Events (AEs), Serious Suspected (SS) cases, and Special Situation Reports (SSRs). Maintain detailed case records including intake forms, investigation notes, follow-ups, and regulatory submissions. 2. Quality Assurance & Compliance Monitoring Conduct internal quality audits of PV data and processes to ensure alignment with SOPs, GVP guidelines, and international regulatory standards (EMA, FDA). Perform quality checks on safety documentation for completeness, accuracy, and consistency. Identify deviations and implement Corrective and Preventive Actions (CAPA) accordingly. 3. Regulatory Readiness & Reporting Contribute to audit summaries, compliance reports, and documentation needed for regulatory inspections. Support internal and external audit preparation and responses to regulatory queries. Ensure that all case management activities are in compliance with local and global safety reporting obligations. 4. SOP Development & Process Improvement Assist in the creation, review, and refinement of Standard Operating Procedures (SOPs), work instructions, and quality manuals in collaboration with the QA team. Monitor and suggest enhancements to improve quality metrics and operational efficiency. 5. Data Security & Confidentiality Ensure secure handling of all patient and safety data in line with HIPAA, GDPR, and company-specific data protection policies. 6. Cross-Functional Collaboration Liaise with internal teams (Medical Affairs, Operations, Regulatory, and IT) to maintain effective quality and compliance standards. Present audit findings, trends, and improvement opportunities to stakeholders. Qualifications and Skills Required Education: Bachelors degree in Healthcare Administration, Life Sciences, Quality Management, or a related field. Certifications: Certified Quality Auditor (CQA) or similar certification is a plus. Experience: 2–5 years in QA, compliance, or pharmacovigilance within the healthcare/pharma industry. Regulatory Knowledge: Familiarity with GVP, EMA, FDA, HIPAA, and other healthcare compliance frameworks. Skills: Strong analytical and problem-solving skills Excellent attention to detail and documentation accuracy Proficient in compliance and QA software tools Strong verbal and written communication skills Ability to multitask and work independently Why Join Us? Be part of a mission-driven organization committed to healthcare safety and regulatory excellence. Work in a collaborative and growth-oriented environment. Competitive salary and professional development opportunities.
