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Operations Specialist 2 - India

5+ years
Not Disclosed
10 May 9, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Operations Specialist 2
Department: Lifecycle Safety
Location: Thane, Maharashtra
Job Type: Full-Time
Application Deadline: 9 May 2025


Job Overview:

The Operations Specialist 2 applies advanced knowledge and expertise to process, assess, and review safety data across service lines, functioning as a recognized subject matter expert. This role includes providing oversight on small to medium operational projects, mentoring junior staff, and ensuring compliance with applicable regulatory and project standards.


Key Responsibilities:

Pharmacovigilance & Safety Data Processing:

  • Execute pharmacovigilance activities including AE/endpoint data collection, tracking, coding, and database entry.

  • Write narratives, manage literature-based activities, quality checks, translations, and reconciliation tasks.

  • Assess data for reportability and coordinate with stakeholders for timely submissions to regulatory bodies.

Operational Oversight & Project Contribution:

  • Lead or contribute to deliverables across Safety Publishing, Risk Management, Medical Information, or related service lines.

  • Support adjudication and case closure as required.

  • Monitor metrics, productivity, and performance for assigned projects.

  • Ensure thorough understanding of project protocols and scope.

Team Collaboration & Communication:

  • Maintain effective communication with project management, clinical, and data teams.

  • Serve as point of contact for clients regarding daily case processing.

  • Provide training, feedback, and mentorship to junior team members.

  • Participate in internal initiatives and process improvement projects.

Compliance & Documentation:

  • Ensure 100% compliance with SOPs, training plans, and project-specific requirements.

  • Maintain accurate documentation for training, communication, and project files.

  • Support audit preparedness and contribute to departmental goals.

Additional Duties:

  • Lead and support team initiatives and meetings.

  • Perform medical review of non-serious AEs/ADRs if applicable.

  • Act as a backup for Operations Manager as needed.


Qualifications & Experience:

  • Education: Bachelor’s Degree in Life Sciences, Healthcare, or related discipline (required).

  • Experience:

    • Up to 5 years in pharmacovigilance, including 3 years minimum in relevant roles.

    • Proven experience in mentoring, coaching, and project oversight.


Skills & Competencies:

  • Strong command of medical terminology and safety databases.

  • Advanced knowledge of global and local clinical research regulations.

  • Proficiency in Microsoft Office and web-based platforms.

  • Excellent attention to detail, time management, and communication skills.

  • Capable of independent work, multitasking, and decision-making.

  • Strong interpersonal, negotiation, and leadership skills.

  • Demonstrates IQVIA core values and adheres to compliance standards.

  • Willingness to work in shifts and travel occasionally.


For more information, visit: IQVIA Careers