Job Title: Manager – Medical Monitor
Company: Syngene International Ltd.
Location: Bengaluru, Karnataka, India
Department: Medical & Regulatory Affairs
Division: Discovery Services
Job Type: Full-Time
Experience Required: Foundational experience (typically 1–3 years in clinical research, pharmacovigilance, or medical monitoring roles)
Education: MBBS with MD in Pharmacology
About Syngene
Syngene International Ltd. is an innovation-driven contract research, development, and manufacturing organization (CRDMO) that provides integrated scientific services from early discovery to commercial manufacturing. The company partners with global pharmaceutical, biotechnology, and healthcare organizations to accelerate drug development and commercialization.
Headquartered in Bengaluru, India, Syngene offers capabilities across discovery research, clinical development, biologics manufacturing, and commercial supply, supporting global healthcare innovation and improving patient outcomes.
Job Summary
Syngene is seeking a qualified physician for the role of Manager – Medical Monitor within the Medical & Regulatory Affairs department. The Medical Monitor plays a critical role in ensuring patient safety, scientific integrity, and regulatory compliance throughout the lifecycle of clinical trials.
The role involves continuous oversight of participant safety, review and interpretation of clinical and safety data, and providing medical guidance during clinical trial design, execution, and reporting. The Medical Monitor collaborates closely with investigators, clinical teams, pharmacovigilance experts, and regulatory professionals to maintain ethical and scientific standards in clinical research.
Core Responsibilities
Provide medical oversight for clinical trials across various therapeutic areas, ensuring participant safety and data integrity.
Review and evaluate adverse events (AEs), serious adverse events (SAEs), and unexpected safety signals to ensure timely risk management.
Interpret clinical and safety data to ensure accuracy, appropriate medical context, and regulatory compliance.
Support preparation and review of clinical trial documentation including Investigator’s Brochure, Informed Consent Forms, Investigator’s Undertakings, and Clinical Study Reports (CSR).
Review MedDRA and WHO Drug Dictionary coding for accuracy and consistency in clinical trial datasets.
Assist senior research physicians in generating SAE narratives and performing safety analyses for clinical trials.
Ensure timely communication of safety events to stakeholders in accordance with regulatory guidelines and internal SOPs.
Lead drafting of Integrated Summary of Safety and Efficacy reports for assigned clinical studies.
Review protocols and protocol synopses for bioavailability (BA), bioequivalence (BE), and clinical phase studies in collaboration with cross-functional teams including clinicians, bioanalytical scientists, statisticians, and regulatory experts.
Develop Medical Monitoring Plans (MMP) and Risk Evaluation and Mitigation Strategies (REMS) where applicable.
Review Safety Management Plans (SMP) for assigned projects when required.
Support preparation of Site Feasibility Questionnaires (SFQs) and related study feasibility documentation.
Provide protocol training to study teams and respond to medical queries from investigators and clinical research staff.
Support preparation of regulatory documents and ensure timely completion of deliverables.
Manage clinical documentation through multiple review cycles while ensuring adherence to project timelines.
Travel to clinical trial sites within India when required to perform medical monitoring activities.
Safety and Compliance Responsibilities
Adhere to Syngene’s safety practices and operational procedures at all times.
Promote a strong culture of environmental, health, and safety (EHS) awareness across teams and project environments.
Ensure compliance with quality standards, data integrity practices, and regulatory guidelines.
Complete all mandatory training related to health, safety, and compliance requirements.
Review safety metrics periodically and ensure adherence to organizational safety objectives.
Leadership and Collaboration
Provide clinical expertise to guide protocol design and safety monitoring strategies.
Support cross-functional collaboration with investigators, clinical operations teams, pharmacovigilance specialists, and data management professionals.
Assist study teams with rapid medical decision-making during safety events or emerging clinical risks.
Mentor junior team members and provide training related to clinical trial safety oversight.
Ensure alignment between operational teams and medical leadership to maintain trial integrity.
Required Skills and Competencies
Strong clinical knowledge and understanding of pharmacology and therapeutic areas relevant to clinical trials.
Ability to evaluate adverse events and serious adverse events accurately and efficiently.
Good understanding of clinical research regulations including ICH-GCP and international regulatory standards.
Strong analytical capabilities for interpreting clinical trial data and identifying safety trends.
Excellent written and verbal communication skills with the ability to translate complex medical information for non-medical stakeholders.
Strong problem-solving abilities for addressing protocol deviations, site challenges, and patient safety concerns.
Ability to collaborate effectively with multidisciplinary clinical research teams.
Experience Required
Candidates should have foundational professional experience (typically 1–3 years) in clinical research, pharmacovigilance, medical monitoring, or related roles within pharmaceutical, biotechnology, or contract research organizations. Experience supporting clinical trials and safety monitoring activities will be highly preferred.
Syngene Core Values
All employees at Syngene are expected to demonstrate alignment with the organization’s core values:
Excellencea
Integrity
Professionalism
Equal Opportunity Statement
Syngene International Ltd. is an equal opportunity employer committed to providing fair employment opportunities to all individuals regardless of age, race, gender, religion, disability, nationality, sexual orientation, or any other protected status under applicable laws. The company also provides reasonable accommodations for qualified individuals with disabilities during the recruitment process.
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