PV PHYSICIAN
Company: ICON plc
Location: Chennai / Bangalore / Trivandrum, India
Work Model: Office With Flex
Department: Drug Safety
Job Type: Full-Time
JOB OVERVIEW
ICON is seeking a Pharmacovigilance (PV) Physician to oversee the medical evaluation and safety assessment of investigational and marketed products. The role involves medical review of adverse event reports, signal evaluation, causality assessment, risk management activities, and contribution to global pharmacovigilance operations. The PV Physician will work closely with cross-functional teams and clients to ensure patient safety and regulatory compliance.
KEY RESPONSIBILITIES
Perform medical review and assessment of adverse event reports from clinical trials and post-marketing sources.
Evaluate clinical significance, seriousness, expectedness, and causality of adverse events.
Provide medical guidance and recommendations on safety-related issues.
Collaborate with pharmacovigilance, clinical development, regulatory, and medical teams.
Contribute to risk management strategies and risk minimization activities.
Support signal detection, signal evaluation, and benefit-risk assessments.
Prepare and review safety-related documents including:
Periodic Safety Update Reports (PSURs)
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs)
Safety Narratives
Aggregate Safety Reports
Monitor emerging safety concerns and medical literature.
Provide scientific and medical input during safety reviews and discussions.
Interact directly with clients and provide safety-related recommendations.
Support regulatory inspections and audits when required.
TECHNICAL SKILLS
Pharmacovigilance
Drug Safety Surveillance
Medical Review
Signal Detection
Signal Evaluation
Causality Assessment
Benefit-Risk Assessment
Safety Reporting
Aggregate Report Review
Risk Management Plans (RMP)
Clinical Trial Safety
Post-Marketing Safety Surveillance
Medical Literature Review
REGULATORY KNOWLEDGE
Good Pharmacovigilance Practices (GVP)
Good Clinical Practice (GCP)
ICH Guidelines
FDA Safety Regulations
EMA Pharmacovigilance Requirements
Global Drug Safety Regulations
Clinical Trial Safety Reporting Requirements
EDUCATIONAL QUALIFICATIONS
Required
MBBS
Preferred
MD
Medical Degree with active medical license
EXPERIENCE
MBBS or MD with minimum 2 years of relevant Drug Safety / Pharmacovigilance experience
Experience in medical review of adverse events
Experience in clinical safety and pharmacovigilance activities
Experience within CRO, pharmaceutical, or biotechnology industry preferred
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
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Japan | Saitama |Tokyo :
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