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 Role s & 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.