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Operations Specialist 2 - India

Iqvia
IQVIA
3-5 years
Not Disclosed
10 May 7, 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 - India
Department: Lifecycle Safety
Location: Thane, Maharashtra
Job Type: Full-Time
Application End Date: 9 May 2025


Job Overview:

The Operations Specialist 2 applies expertise in safety data management and pharmacovigilance to review, assess, and process complex safety information. This role involves decision-making, regulatory reporting, team mentorship, and client communication while ensuring project compliance and quality standards.


Key Responsibilities:

  • Process safety data in line with applicable regulations, guidelines, SOPs, and project requirements.

  • Conduct pharmacovigilance activities, including:

    • Collecting and tracking adverse events (AE) and endpoint data

    • Determining event status (initial/update)

    • Database entry, AE and product coding, narrative writing, and literature handling

  • Execute quality review, reconciliation, case closure, and translation coordination tasks.

  • Perform adjudication-related activities and assess safety data for reportability.

  • Liaise with regulatory authorities and stakeholders to ensure timely reporting and compliance.

  • Contribute to or lead Safety Publishing, Risk Management, Medical Information, and other service line deliverables.

  • Support training and mentoring for junior staff; serve as backup to Operations Manager as needed.

  • Maintain detailed knowledge of project scope, protocol, budget, and status metrics.

  • Establish strong communication with internal teams and external stakeholders.

  • Ensure 100% compliance with training and SOP acknowledgment requirements.

  • Participate in department initiatives, process efficiency projects, and audits.

  • May perform medical review of non-serious AEs/ADRs, ensuring data completeness and regulatory alignment.


Required Qualifications:

  • Education: Bachelor's degree in life sciences, healthcare, or related field (Required)

  • Experience: Up to 5 years of relevant experience, including 3 years in Pharmacovigilance (Required)

  • Preferred: Equivalent education/training/experience combinations


Key Skills & Competencies:

  • Strong understanding of medical terminology and global regulatory requirements

  • Proficiency in safety databases and client/internal applications

  • Excellent project management, organizational, and time management skills

  • High attention to detail, quality, and accuracy

  • Advanced communication, leadership, and mentoring abilities

  • Ability to multitask, meet strict deadlines, and manage team priorities

  • Flexible, self-motivated, with sound judgment and problem-solving skills

  • Team-oriented with a commitment to departmental goals and quality deliverables

  • Willingness to work in shifts and travel as required


Company Profile:
IQVIA is a global leader in clinical research, healthcare analytics, and technology services. It connects data and science to help accelerate medical innovations and improve health outcomes. Learn more at
jobs.iqvia.com.