IQVIA Vigilance platform Specialist
- Smart Ims
- 7 - 12 years
- Hyderabad
- 4 months ago
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Job Description
Job Summary
We are seeking a Pharmacovigilance (PV) Specialist with expertise in IQVIA vigilance platforms to support drug safety operations, adverse event reporting, and regulatory compliance. The ideal candidate will have hands-on experience with pharmacovigilance databases, safety case processing, signal detection, and regulatory submissions in accordance with global health authority guidelines.
Key Responsibilities
- Manage and process adverse event (AE) and serious adverse event (SAE) reports within the vigilance platform.
- Ensure compliance with FDA, EMA, MHRA, PMDA, and other global pharmacovigilance regulations.
- Perform data entry, case assessment, MedDRA coding, narrative writing, and quality control (QC) review of safety cases.
- Conduct signal detection, risk management, and benefit-risk assessment activities.
- Support Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
- Ensure timely submission of ICSRs (Individual Case Safety Reports), SUSARs (Suspected Unexpected Serious Adverse Reactions), and aggregate reports.
- Work closely with cross-functional teams, including medical affairs, regulatory, and clinical teams, to ensure seamless pharmacovigilance operations.
- Assist in audit and inspection readiness, ensuring compliance with standard operating procedures (SOPs) and best practices.
- Provide training and support to internal teams on vigilance platform usage and pharmacovigilance workflows.
Required Skills & Qualifications
- 5+ years of experience in pharmacovigilance, drug safety, or related fields.
- Strong experience with vigilance platforms (e.g., Argus Safety, ArisG, Veeva Vault Safety, or other PV databases).
- Knowledge of MedDRA, WHO Drug Dictionary, ICH E2B guidelines, and case processing workflows.
- Familiarity with signal detection tools and methodologies.
- Experience with global regulatory requirements for safety reporting.
- Strong analytical, problem-solving, and communication skills.
- Ability to work in fast-paced environments with cross-functional teams.
Nice to Have
- Experience in Artificial Intelligence (AI) and automation tools for pharmacovigilance.
- Knowledge of programming languages (SQL, Python) for PV data analytics.
- Certifications in Pharmacovigilance or Drug Safety (DIA, RQA, or equivalent).
Job Classification
Industry: IT Services & ConsultingFunctional Area / Department: Healthcare & Life Sciences, Role Category: Healthcare & Life Sciences - OtherRole: Healthcare & Life Sciences - OtherEmployement Type: Full timeContact Details:
Company: Smart ImsLocation(s): Hyderabad+ View Contact
Keyskills: Vigilance Pharmacovigilance IQVIA
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₹ 15-30 Lacs P.A
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