Senior Physician, Patient Safety
Location: India (Remote)
Job Category: Medical Sciences / Pharmacovigilance / Drug Safety
Job ID: R0000038057
About the Role:
Parexel is seeking a highly skilled Senior Physician, Patient Safety to lead pharmacovigilance, medical monitoring, and drug safety activities for global clinical programs. The role provides medical review, analysis, and guidance for safety reports while acting as a Subject Matter Expert (SME) in designated therapeutic areas. The Senior Physician will mentor junior staff, support complex case evaluations, and ensure compliance with global drug safety regulations.
Key Responsibilities:
Medical Review & Patient Safety:
Conduct medical reviews of adverse events (including complex and challenging cases), clinical trial cases, and literature cases in compliance with SOPs and client guidelines.
Assess seriousness, causality, expectedness, and clinical relevance of reported events.
Provide expert guidance to case processing teams and junior physicians on case assessment.
Review coding of adverse events, medical histories, and concomitant medications for accuracy.
Aggregate Safety Reporting:
Review and/or author key pharmacovigilance documents, including PBRERs, PSURs, DSURs, Signal Evaluation Reports (SERs), Health Hazard Evaluation reports (HHEs), Clinical Overviews, Addenda to Clinical Overviews, and other safety reports.
Support preparation of regulatory submissions and Health Authority responses.
Provide oversight and inputs to medical writers preparing safety reports.
Signal Detection & Risk Management:
Conduct signal detection, validation, and medical assessment activities in line with SOPs.
Author or review signal reports and provide medical guidance for risk management.
Contribute to safety management meetings and prepare relevant documentation for regulatory and internal stakeholders.
Therapeutic Area Expertise:
Act as a therapeutic area SME, providing specialized knowledge to optimize drug safety processes.
Mentor junior physicians and provide guidance to enhance clinical and pharmacovigilance capabilities.
Contribute to strategic planning, internal training programs, and cross-functional safety initiatives.
Clinical & Regulatory Support:
Provide medical oversight for clinical protocols, integrated clinical and statistical summary reports, Investigator Brochures, and other safety-related documentation.
Participate in internal and external meetings, including regulatory authority discussions, investigator meetings, and training sessions.
Conduct literature review for safety assessment and provide MAH comments as needed.
Qualifications & Experience Required:
Medically qualified with MBBS, MD, or equivalent from a recognized medical school.
Completion of basic clinical training (internship/residency).
Minimum 5–8 years of relevant experience in pharmacovigilance, patient safety, or clinical medicine within pharmaceutical, biotech, or CRO environments.
Strong knowledge of international drug regulations including ICH GCP, GVP, FDA, EMA, and other applicable guidelines.
Proven experience in medical monitoring, pharmacovigilance reporting, and safety signal management.
Ability to mentor junior physicians and lead complex safety evaluations.
Skills & Competencies:
Excellent clinical judgment with the ability to interpret complex medical data.
Strong analytical, organizational, and communication skills.
Proficiency in Microsoft Office and web-based pharmacovigilance tools.
Flexible and collaborative mindset, able to work effectively in a global matrix environment.
Detail-oriented, with a strong focus on compliance, quality, and patient safety.
Why Join Parexel:
Parexel is a leading global CRO that accelerates the development of life-changing therapies. By joining our team, you will:
Work on challenging global clinical programs with cutting-edge science.
Develop your expertise in pharmacovigilance and patient safety.
Collaborate with cross-functional teams and contribute to impactful regulatory decisions.
Apply Now to be part of a global organization committed to advancing patient safety and improving healthcare outcomes.
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