Job Title: Senior Physician – Patient Safety
Job ID: R0000036744
Category: Medical Sciences / Pharmacovigilance
Location: India (Remote)
Employment Type: Full-Time
Parexel, a global leader in clinical research and drug development services, is seeking an experienced Senior Physician – Patient Safety to support global pharmacovigilance and medical monitoring activities. This remote-based role in India is ideal for medically qualified professionals with strong expertise in drug safety, adverse event assessment, and regulatory compliance.
As a Senior Physician in Patient Safety, you will serve as a medical and safety subject matter expert, providing clinical judgment, oversight, and strategic input across complex pharmacovigilance activities while mentoring junior physicians and collaborating with global stakeholders.
Perform medical and safety monitoring activities for assigned clinical trials and post-marketing projects.
Conduct expert medical review of adverse event cases, including complex, challenging, clinical trial, literature, and combination product (drug–device) cases, in accordance with SOPs and regulatory requirements.
Assess seriousness, expectedness/listedness, causality, and medical coherence of case narratives.
Provide MAH comments, medical analysis, and guidance for safety reports and regulatory submissions.
Support case processing teams with expert medical input, follow-up strategies, and MedDRA coding review.
Maintain in-depth knowledge of assigned products’ safety profiles, labeling, and global drug safety regulations (ICH GCP, GVP, and applicable guidelines).
Ensure compliance with internal processes and global regulatory reporting timelines.
Act as pharmacovigilance representative and safety scientist for assigned projects.
Support audits, inspections, and bid defense meetings as required.
Review and assess scientific literature for product safety evaluation and emerging safety signals.
Provide expert medical summaries, MAH comments, and inputs for aggregate reports and signal management activities.
Offer medical guidance to PV and study teams on safety-related topics.
Serve as a Subject Matter Expert within assigned therapeutic areas, supporting safety strategy and decision-making.
Collaborate with Therapeutic Area Leads to strengthen scientific and medical expertise across teams.
Mentor and train junior Patient Safety Physicians, fostering professional development and knowledge sharing.
Contribute to process improvement initiatives, training programs, and cross-functional safety projects.
Education:
MBBS, MD, or equivalent medical degree from a recognized medical school.
Completion of basic clinical training (internship, residency, or equivalent).
Experience Required:
Minimum 2 years of experience in pharmacovigilance, patient safety, or medical monitoring activities.
Demonstrated clinical medicine experience (general or specialty), maintained with current medical knowledge.
Technical & Professional Skills:
Strong understanding of drug development and global drug safety regulations (ICH GCP, GVP).
Proven ability to perform complex medical evaluations and exercise sound clinical judgment.
Experience mentoring junior physicians or safety professionals.
Excellent written, verbal, and presentation skills with a client-focused mindset.
Proficiency in Microsoft Office and web-based safety systems.
Ability to manage multiple priorities in a matrix, remote, and global environment.
Senior Physician Patient Safety, Pharmacovigilance Physician, Drug Safety Medical Review, Medical Monitoring, Adverse Event Assessment, ICH GCP, GVP Compliance, MedDRA Coding, Signal Detection, Literature Review, Regulatory Safety Reporting, Clinical Drug Safety, Remote Pharmacovigilance Jobs India.
Parexel is driven by a shared commitment to improve global health by accelerating the development of life-changing therapies. The organization offers a collaborative, science-driven environment with opportunities to work on diverse therapeutic areas, complex global projects, and continuous professional growth.
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