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Associate Manager - Quality Assurance

0-2 years
Not Disclosed
10 Sept. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Manager – Quality Assurance

Date Posted: 29 Aug 2025
Location: Bangalore, KA, India


Company Overview:

Indegene is a technology-led healthcare solutions provider enabling healthcare organizations to be future-ready. The company offers accelerated global growth opportunities for talent that is bold, industrious, and nimble. Employees gain a unique career experience guided by passion, innovation, collaboration, and empathy.

Key highlights:

  • Exposure to pharmacovigilance (PV) quality management and compliance

  • Mentorship from industry experts

  • Fast-track global career growth opportunities


Role Purpose:

The Associate Manager – Quality Assurance is responsible for ensuring compliance, quality, and regulatory adherence in pharmacovigilance processes. The role involves overseeing PV activities, training staff, risk management, documentation, and cross-functional collaboration.


Key Responsibilities:

1. Quality Management:

  • Develop, review, and update PV policies, procedures, and SOPs to ensure compliance and currency.

  • Monitor and report PV compliance metrics and trends.

  • Implement and maintain PV quality management systems.

  • Oversee evaluation and consistent handling of adverse events, ensuring reporting timelines and quality standards are met.

  • Communicate observations to stakeholders and ensure proper root cause analysis (RCA) and corrective/preventive action (CAPA).

  • Present quality data to internal stakeholders and attend internal/client trainings.

2. Training and Support:

  • Provide training on PV regulations, compliance requirements, and company SOPs.

  • Act as a subject matter expert for PV compliance queries.

  • Set up development plans for team members to enhance skills and potential.

  • Design training plans for new hires based on experience and job role.

3. Risk Management:

  • Identify, assess, and mitigate risks related to PV activities.

  • Develop and maintain risk management plans and implement mitigation strategies.

4. Documentation and Reporting:

  • Ensure accurate and timely documentation of compliance activities.

  • Prepare compliance reports for senior management and regulatory authorities.

  • Maintain inspection readiness documentation.

  • Review, author, and update SOPs, supporting global quality and compliance initiatives.

5. Regulatory Compliance and Late Case Analysis:

  • Ensure compliance with global PV regulations and guidelines (e.g., FDA, EMA, ICH, MHRA).

  • Stay updated on changes in PV regulations and implement adjustments.

  • Conduct investigations into root causes of delayed case processing and submissions.

6. Cross-functional Collaboration:

  • Work with Clinical, Regulatory Affairs, and QA departments to ensure coordinated PV activities.

  • Participate in cross-functional teams for PV compliance initiatives.


Skills & Competencies:

  • Strong attention to detail

  • Critical thinking and analytical skills

  • Good comprehension skills

  • Excellent communication (verbal and written) and interpersonal skills

  • Proficiency in Excel

Nice to have:

  • Team and people management experience

  • Certification in Quality Management Systems (QMS)


Equal Opportunity:

Indegene is committed to a culture of inclusion and diversity. Employment decisions are based on business requirements, merit, and qualifications.

All qualified applicants will receive consideration without regard to:

  • Race, color, religion, sex, national origin

  • Gender identity or sexual orientation

  • Disability status or protected veteran status