Drug Safety Physician – Remote
Location: Remote (India-based)
Employment Type: Full-Time
Experience: 1–4 Years
About the Role
We are looking for a Drug Safety Physician with strong medical and pharmacovigilance expertise to support ICSR review, case triage, and safety assessment across multiple therapeutic areas. This role requires clinical knowledge, analytical skills, and the ability to ensure compliance with global regulatory standards while managing quality, documentation, and team deliverables.
This position offers a remote work option while enabling collaboration with global pharmacovigilance teams, clinical operations, and regulatory stakeholders.
Key Responsibilities
Medical Assessment & Case Management
Acquire comprehensive knowledge of assigned product portfolios and their safety profiles.
Conduct medical assessment and analysis of ICSRs, adverse events, and safety information from clinical trials and post-marketing sources.
Triaging cases and determining seriousness, causality, and reportability for assigned products.
Review source documents, assign appropriate MedDRA codes, and draft/review case narratives.
Ensure all assigned projects and safety processes are compliant with client agreements, regulations, and internal SOPs.
Quality, Compliance & Documentation
Maintain high-quality documentation and compliance across assigned projects.
Take ownership of projects and tasks, ensuring adherence to timelines and quality standards.
Participate in audits and inspections, representing the pharmacovigilance function as needed.
Author, review, and maintain SOPs and other department-relevant documentation.
Team Management & Training
Manage and monitor the workload of assigned personnel.
Provide line management, mentorship, and training to team members.
Identify new training and development requirements relevant to the function.
Act as a point of contact for internal and external stakeholders to ensure compliance and address issues.
Other Responsibilities
Perform additional tasks and responsibilities as assigned by management.
Continuously collaborate with internal and external stakeholders to ensure smooth project execution and regulatory compliance.
Required Skills & Qualifications
Medical degree (MD/MBBS) or equivalent with 1–4 years of experience in drug safety, pharmacovigilance, or clinical operations.
Strong understanding of ICSR processing, case triage, adverse event assessment, and MedDRA coding.
Knowledge of global pharmacovigilance regulations and guidelines (ICH, GVP, FDA, EMA).
Experience in team management, mentoring, and training within a pharmacovigilance or clinical safety setting.
Excellent communication, documentation, and analytical skills.
Ability to manage multiple projects and meet deadlines in a remote work environment.
Why Join
Play a key role in global pharmacovigilance operations supporting drug safety and regulatory compliance.
Opportunity to work remotely with structured projects and global stakeholders.
Enhance your expertise in medical case assessment, pharmacovigilance processes, and regulatory compliance.
Contribute to patient safety and global healthcare outcomes across multiple therapeutic areas.
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
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Tel Aviv | Netanya | Be'Er Sheva | Kfar Saba | Yavne |Remote :
Bishop | Blue Bell | Remote - South America (Latin Americal) | Melbourne | Nairobi | Remote - Middle East | Regulatory Labeling Manager (NA and LATAM Only) | Faridabad | Ireland | Tulsa | Zaragoza | Remote - Europe | Lenexa | McFarland | Hammond | Medan | Minnesota | Remote - Africa | Riga | Victoria | Castlebar | Lousiana | Springville | French | Bountiful | Hungary | Slovakia | Leinster | Remote, USA | Green Way | Remote | Thailand | Switzerland | Manipal | Xzagreb | Texas | Belgium |Republic of Colombia :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
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Prague |Chile :
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