Job Title: Medical Physician Specialist II
📍 Location: Pune
🏢 Category: Clinical
🆔 Job ID: 255097
Job Overview
The Medical Physician Specialist II provides medical safety expertise for drugs, devices, and combination products during the post-marketing period.
The role involves case review, medical assessment, training, and signal detection while ensuring adherence to quality, compliance, and productivity standards.
Key Responsibilities
🧠 Case Medical Review & Assessment
Conduct primary medical reviews of cases.
Perform medical assessments for:
Seriousness
Listedness/Labeling
Causality
Adverse Event (AE) Coding
Narrative Review
Update and document daily case data and feedback in relevant trackers/tools for workflow and tracking.
📋 Deliverable Management
Take full responsibility for assigned deliverables ensuring:
Expected quality
Compliance with regulatory and client standards
Productivity SLAs & KPIs are achieved
👩🏫 Training & Mentorship (After 1 Year Tenure)
Provide medical training and guidance to case processing teams on clinical aspects of safety review.
Support continuous learning and medical accuracy within the team.
🔍 Quality & Secondary Review (After 1+ Year Tenure)
Conduct secondary medical reviews (QC role).
Perform retrospective QA reviews to:
Measure quality of deliverables
Identify error trends
Highlight training needs and process improvement areas
📈 Signal Detection & Aggregate Review
Participate in aggregate medical reviews.
Support signal detection and trend analysis to identify potential product safety concerns.
🤝 Client & Relationship Management
Build and enhance client relationships through effective communication.
Maintain a culture of high-quality service delivery and customer satisfaction.
🔄 Process Improvement
Actively participate in continuous process improvement initiatives across teams and functions.
Minimum Qualifications
🎓 Education:
Bachelor’s Degree in Medical Science, MD, DO, or equivalent.
Relevant experience may be considered in lieu of formal educational requirements.
🗣️ Language Proficiency (English):
Speaking: ILR Level 3+ or higher
Reading/Writing: ILR Level 4+ or higher
Experience (Minimum Required)
Sound knowledge of medical sciences, diagnosis, and therapeutics (including drug treatments and procedures).
Understanding of regulatory requirements for Clinical Research.
Familiarity with ICH-GCP Guidelines.
Preferred Qualifications
✅ Strong understanding of Pharmacovigilance regulations and compliance.
✅ Up to 1 year of pharmaceutical industry experience, preferably in:
Pharmacovigilance (Case Processing / Medical Review)
Clinical Research
✅ 1–2 years of clinical practice experience (medical setting).
Key Competencies
Analytical thinking and clinical judgment
Attention to detail and documentation accuracy
Effective communication and team collaboration
Commitment to compliance and data integrity
Customer service mindset with focus on quality delivery
Work Environment
🏠 Office-based or Home-based (as per line manager’s direction)
💼 Standard office conditions; no special physical demands.
Equal Opportunity Statement
We are an Equal Opportunity Employer and committed to providing reasonable accommodations where required.
📎 Learn more about our EEO & Accommodation Policy [here].
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