Senior Associate, Medical Review Physician

ClinChoice; Pasig; On-site; PHP 600,000 - 900,000; Full time

Job summary

ClinChoice Philippines is seeking a Medical Physician with at least 2 years of experience as a Medical Reviewer for IC SRS to join our pharmacovigilance team. You will conduct medical reviews focusing on seriousness, causality, and narrative quality, ensuring compliance with ICH-GCP, GVP modules, and applicable regulatory guidelines.

You will work across multiple therapeutic areas, mentor junior staff, and help improve quality control processes while maintaining safety databases and meeting

Qualifications

• Medical Physician with at least 2 years of experience as Medical Reviewer for IC SRS.
• Thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and regulatory requirements.
• Hands-on experience with MS Office applications (Outlook, Excel, Word, PowerPoint).

Responsibilities

• Awareness and understanding of relevant GVP modules.
• Perform medical review of non-serious & serious IC SRS with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
• Experience of medical review of IC SRS from Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
• Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc.
• Support triage of cases and determine seriousness and relatedness across products as assigned.
• Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative.
• Acquire and maintain current knowledge of product portfolio and safety profiles across therapeutic areas.
• Involve in process improvement activities such as implementation of quality control process.
• Provide medical guidance and expert opinion on the cases to data entry associates and quality reviewers to help resolve queries.
• Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
• Maintain PV expertise and understanding of international safety regulations and guidelines.
• Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
• Provide timely feedback to case processors on the errors/ discrepancies noted.
• Assist in training/mentoring of other case processing/medical review personnel as necessitated.
• Adapt to different client case processing conventions and multi-task as per business needs.
• Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
• Participate in organizational activities to meet objectives suitable for the role/area of expertise.

Skills

Medical Reviewer

Regulatory knowledge

Education

Medical Doctor (MD)

Tools

MS Office

Job description

Primary Responsibilities:

• Awareness and understanding of relevant GVP modules.
• Perform medical review of non-serious & serious IC SRS with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
• Experience of medical review of IC SRS received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
• Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc.
• Support triage of cases and determine seriousness and relatedness across products as assigned.
• Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative.
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
• Involve in process improvement activities such as implementation of quality control process.
• Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries.
• Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
• Maintain PV expertise and understanding of international safety regulations and guidelines.
• Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
• Provide timely feedback to case processors on the errors/ discrepancies noted.
• Assist in training/mentoring of other case processing/medical review personnel as necessitated.
• Adapt to different client case processing conventions and multi-task as per business needs.
• Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
• Participate in organizational activities to meet objectives suitable for the role/area of expertise.

Candidate Profile:

• Medical Physician with at least 2 years of experience as Medical Reviewer for IC SRS.
• Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
• Training and mentoring skills (GVP concepts & medical aspects such as disease condition, product portfolio etc).
• Must have hands-on experience with MS Office applications (Outlook, Excel, Word, Power Point etc).