Lead - Clinical Literature Monitoring

Job Title: Lead Associate – Clinical Literature monitoring

Department: Pharmacovigilance

Location: Remote, India

Knowledge and Application:

• Proficient in biomedical literature screening, abstracting, and indexing.
• Basic working knowledge of biomedical literature, pharmacovigilance, and regulatory reporting.
• Familiarity with information storage and retrieval systems and copyright compliance.
• Understanding of US and ex-US pharmaceutical regulations and adverse event reporting requirements.

Key Responsibilities and Authorities

Job Roles & Responsibility:

• Perform high-quality screening, abstracting, and indexing of biomedical literature.
• Develop and maintain article selection, editorial, and indexing policies in collaboration with stakeholders.
• Train screeners, abstractors, and internal team members.
• Liaise with pharmacovigilance teams to meet adverse event monitoring requirements.
• Assist in managing literature-related systems and databases to ensure data integrity and compliance.
• Collaborate with IT to maintain the Company Product Literature Database and support end-user system development.
• Participate in data processing, harmonization, and terminology standardization activities.

Business Impact:

• Ensure timely and accurate delivery of literature monitoring outputs to support regulatory, clinical research, and marketing functions.
• Enhance compliance with regulatory and pharmacovigilance requirements, mitigating risks related to adverse event reporting.
• Optimize the performance and reliability of literature-related systems to improve efficiency and data utilization.

Collaboration & Interaction:

• Work closely with internal teams, including regulatory groups, pharmacovigilance teams, and IT.
• Collaborate with external organizations for literature-related system integration and compliance.
• Engage stakeholders to address their literature-related requests and support system developments.

Span of Control / Supervision:

• Individual contributor with responsibilities for training and mentoring junior team members.
• Supports and coordinates tasks across multiple stakeholders.

Qualifications & Certifications

Education Qualification:

Bachelor or post-graduate degree in Computer Science or related field.

Professional Qualification:

• 5+ years of experience with biomedical literature and pharmacovigilance.
• Familiarity with semantic technologies, NLP, ML, or AI is a plus.
• Knowledge of SDLC and copyright compliance preferred.
• Exposure to audits and inspections. Proficiency in literature monitoring systems and biomedical database management.