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Senior Physician, Patient Safety

Parexel
Parexel
2 years
preferred by company
10 Jan. 16, 2026
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Physician – Patient Safety (Pharmacovigilance)
Location: India (Remote)
Category: Medical Sciences / Patient Safety
Job ID: R0000036744
Employment Type: Full-Time


Job Overview

Parexel is seeking an experienced Senior Physician – Patient Safety to support global pharmacovigilance and medical monitoring activities across assigned projects. This senior-level role is responsible for providing expert medical review, safety analysis, and clinical judgment for complex safety cases, aggregate reports, and signal management activities.

The Senior Physician will function as a Subject Matter Expert (SME) within assigned therapeutic areas, collaborate with cross-functional stakeholders, and mentor junior physicians. This position requires strong clinical expertise, in-depth knowledge of global drug safety regulations, and the ability to lead complex safety evaluations in a global, matrix-driven environment.


Key Responsibilities

General Patient Safety & Pharmacovigilance

  • Maintain in-depth knowledge of adverse event profiles, product labeling, safety data handling conventions, client procedures, and global pharmacovigilance regulations

  • Ensure compliance with global regulatory reporting requirements and internal timelines for adverse event and safety reporting

  • Communicate safety-related issues with Line Managers, Project Leads, and cross-functional stakeholders

  • Participate in and present at client and cross-functional meetings as a Patient Safety SME

  • Support audits, inspections, and regulatory readiness activities

  • Contribute to continuous process improvement initiatives and achievement of defined KPIs

  • Act as a pharmacovigilance representative and safety scientist on assigned projects

  • Support bid defense activities, feasibility assessments, and project transitions

  • Mentor and coach Patient Safety Physicians and junior team members


Medical Review & Case Assessment

  • Perform medical review of complex and challenging individual case safety reports (ICSRs), including clinical trial, post-marketing, and literature cases, in accordance with SOPs

  • Write Medical / MAH comments and assess company causality

  • Review narratives for medical accuracy, coherence, and regulatory compliance

  • Assess seriousness, expectedness, and listedness of adverse events

  • Provide medical input to case processing teams and raise appropriate follow-up queries with reporters or healthcare professionals

  • Ensure accurate MedDRA coding and selection of adverse events from source documents

  • Identify, investigate, and resolve complex case issues in collaboration with therapeutic, legal, and client teams

  • Provide guidance to junior physicians on medical assessment methodologies


Literature Review & Signal Management

  • Review scientific literature for product safety evaluation and identification of potential safety signals

  • Perform literature triage, summarization, and MAH commentary for aggregate reports and signal management activities

  • Provide expert medical guidance to pharmacovigilance and study teams


Therapeutic Area Expertise

  • Serve as a Therapeutic Area SME, providing strategic medical input to drug safety initiatives

  • Collaborate with Therapeutic Area Leads to enhance scientific and operational excellence

  • Contribute to development and delivery of targeted training programs

  • Participate in internal and external scientific forums, publications, and thought leadership activities

  • Mentor junior physicians within the therapeutic area and support professional development

  • Identify emerging trends, risks, and innovation opportunities within the therapeutic area


Required Qualifications

  • MBBS, MD, or equivalent medical degree from a recognized medical school

  • Completion of basic clinical training (internship, residency, or equivalent)


Experience Requirements

  • Minimum Experience:

    • At least 2 years of hands-on experience in pharmacovigilance, patient safety, or medical monitoring

  • Demonstrated clinical experience in general medicine or a medical specialty

  • Experience mentoring or supervising junior medical or safety professionals is required


Required Skills & Competencies

  • Strong clinical judgment and ability to assess the clinical relevance of safety data

  • In-depth knowledge of global drug development and pharmacovigilance regulations, including ICH-GCP, GVP, and related guidelines

  • Excellent written and verbal communication and presentation skills

  • Strong interpersonal and stakeholder management capabilities

  • Ability to work on complex, high-impact tasks requiring detailed evaluation

  • Proficiency in MS Office, Windows-based systems, and web-based pharmacovigilance tools

  • Ability to manage multiple priorities in a fast-paced, matrix organization

  • Client-focused mindset with strong problem-solving and decision-making abilities

  • Flexible, proactive approach to work and continuous learning


Work Environment

  • Remote-based role within India

  • Global collaboration with cross-functional and international teams