Job Description – Drug Safety Physician
Company:
ICON plc
Remote Type:
Office with Flex
Location:
India, Chennai
India, Trivandrum
Time Type:
Full-time
Posted On:
6 Days Ago
Job Requisition ID:
JR134262
About ICON
ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive, innovative environment and are dedicated to shaping the future of clinical development.
Role Overview
As a Drug Safety Physician, you will oversee the medical aspects of pharmacovigilance activities, ensuring the safety of investigational drugs and supporting the development of innovative treatments and therapies.
Key Responsibilities
Safety Case Review
Review coding (e.g., MedDRA) and assess seriousness, expectedness, listedness, and relatedness of adverse events (serious/non-serious) and adverse drug reactions (serious/non-serious).
Review aggregated safety reports such as patient profiles, line listings, IND Annual Reports, Annual Safety Reports, and Periodic Safety Update Reports.
Pharmacovigilance Support
Support Drug Information & PV Product Support Center: provide product information, review adverse reactions, and ensure compliance.
Assess safety issues in clinical trials or post-marketing, escalate to line manager, and align on resolution with client.
Provide guidance on regulatory requirements for expedited and periodic reporting of AEs/ADRs from trials, post-authorization studies, spontaneous reports, and literature.
Project & Regulatory Support
Review and provide input to Project Specific Procedures and participate in project meetings.
Communicate with clients per Project Specific Procedures.
Assist in preparation and conduct of code-break activities.
Review and contribute to clinical trial protocols, product information, Company Core Data Sheets (CCDS), and other client-required documents.
Provide consultancy to clients on safety information and regulatory requirements.
Team Guidance
Provide training and guidance to Medical and Safety Services staff on regulatory reporting of adverse events.
Contribute to overall pharmacovigilance strategy and client support.
Perform additional responsibilities as assigned.
Your Profile
Education: Medical degree (MD or equivalent) with active medical license.
Specialization: Board certification or equivalent experience in internal medicine, pharmacology, or related specialty.
Experience: Prior experience in pharmacovigilance or drug safety (pharma/biotech) preferred.
Strong clinical judgment and analytical skills for interpreting complex medical data.
Excellent communication, teamwork, and collaboration skills.
What ICON Can Offer You
Competitive salary plus country-specific benefits.
Work-life balance & well-being programs, including:
Various annual leave entitlements.
Health insurance plans for employees and families.
Competitive retirement savings plans.
Global Employee Assistance Programme (TELUS Health) with 24/7 access to specialized professionals.
Life assurance.
Optional flexible benefits (childcare vouchers, gym memberships, travel passes, health assessments, bike purchase schemes, etc.).
Inclusion & Belonging
ICON is committed to diversity, equity, and inclusion.
We provide a workplace free of discrimination and harassment.
Equal consideration for applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Reasonable accommodations are available for candidates with medical conditions or disabilities.
Additional Information
Not sure if you meet all requirements? ICON encourages you to apply — you may still be the right fit.
Current ICON employees should apply via the internal portal.
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