Independent Literature QC Specialist

TheClinixAI; Hyderabad; Hybrid; INR 1,000,000 - 1,450,000; Full time

Benefits offered by this job

Job summary

TheClinixAI is seeking a pharmacovigilance literature surveillance QC professional in Hyderabad with 3+ years of experience. You will perform independent QC of literature screening and review decisions against SOPs, ensuring traceability and error-free outputs.

You will challenge screening decisions, verify bibliographic details, escalate potential safety information, and contribute to CAPA discussions while maintaining independence from first-line decisions.

Qualifications

• Bachelor's or master's degree in Pharmacy, Life Sciences, Medicine or related discipline.
• 3+ years of pharmacovigilance literature surveillance, screening or literature QC experience.
• Strong understanding of PV literature workflows, relevance criteria and ICSR concepts.
• Excellent analytical skills and confidence challenging decisions using evidence and SOP requirements.
• Strong documentation and written communication skills.

Responsibilities

• Perform independent QC of literature search, retrieval, screening and review activities against approved SOPs and client requirements.
• Review inclusion/exclusion decisions, relevance assessments and documented rationales for consistency and traceability.
• Verify bibliographic details, source retrieval, duplicate handling and article-to-case linkage where applicable.
• Assess whether potential safety information has been appropriately identified and escalated.
• Review literature-derived ICSR identification and downstream documentation where applicable.
• Document QC findings with clear evidence, severity and corrective recommendations.
• Identify recurring error patterns and contribute to root-cause and preventive-action discussions.
• Support QC metrics, trend analysis, calibration exercises and process improvement.
• Remain independent from first-line screening decisions when performing second-person QC.

Job description

Hyderabad / Remote · 3+ years experience · Literature Surveillance

About the role

Provide independent quality review of pharmacovigilance literature surveillance and screening activities. This role is responsible for challenging screening decisions, checking source-to-decision traceability and identifying process or case-impacting errors before work is finalized.

Key responsibilities

• Perform independent QC of literature search, retrieval, screening and review activities against approved SOPs and client requirements.
• Review inclusion/exclusion decisions, relevance assessments and documented rationales for consistency and traceability.
• Verify bibliographic details, source retrieval, duplicate handling and article-to-case linkage where applicable.
• Assess whether potential safety information has been appropriately identified and escalated.
• Review literature-derived ICSR identification and downstream documentation where applicable.
• Document QC findings with clear evidence, severity and corrective recommendations.
• Identify recurring error patterns and contribute to root-cause and preventive-action discussions.
• Support QC metrics, trend analysis, calibration exercises and process improvement.
• Remain independent from first-line screening decisions when performing second-person QC.

Required qualifications

• Bachelor's or master's degree in Pharmacy, Life Sciences, Medicine or related discipline.
• 3+ years of pharmacovigilance literature surveillance, screening or literature QC experience.
• Strong understanding of PV literature workflows, relevance criteria and ICSR concepts.
• Excellent analytical skills and confidence challenging decisions using evidence and SOP requirements.
• Strong documentation and written communication skills.

Preferred skills

• Experience with PubMed, Embase, Scopus or other literature sources.
• Experience with literature surveillance platforms and PV safety databases.
• Knowledge of GVP Module VI and relevant literature-surveillance expectations.
• Experience with calibration, sampling plans, QC metrics and CAPA support.