Careers at iPharmX

Pharmacovigilance Consultant

About the Role

As a Pharmacovigilance Consultant, you will support all safety-related activities across clinical Trials and Post-marketing in compliance with MFDS requirements.

Key Responsibilities

• Perform end-to-end Clinical Trials and Post marketing Pharmacovigilance activities
• Perform ICSR management and Clinical trial safety submissions to MFDS
• Contribute to the development, periodic review, and maintenance of pharmacovigilance Standard Operating Procedures (SOPs) and related work instructions
• Support inspection and audit readiness by participating in internal/external audits and following up on Corrective and Preventive Actions (CAPAs)
• Deliver or support PV-related training for both client-facing teams and internal staff members
• Maintain proactive and professional communication with clients and internal stakeholders regarding project timelines, safety deliverables, and compliance expectations
• Ensure all activities are performed in accordance with client-specific procedures and iPharmX quality and compliance standards
• Monitor and meet key performance indicators (KPIs) and coordinate closely with the Project Manager to ensure timely and accurate deliverables
• Manage translation activities as required

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, Nursing, or related discipline
• Based in South Korea and minimum 5 years' local PV experience
• In-depth understanding of global PV regulations with hands-on pharmacovigilance experience with the Ministry of Food and Drug Safety (MFDS), South Korea
• Fluent in English and Korean

Pharmacovigilance Specialist

About the Role

As a Pharmacovigilance Specialist, you will support all safety-related activities across clinical development and post-marketing phases on behalf of our clients. You will be responsible for Individual Case Safety Report (ICSR) management, Clinical Trial submissions, literature review, aggregate report contributions and signal management support, ensuring compliance with the Drug Administration of Vietnam (DAV) and National DI & ADR Centre.This is a hands-on role ideal for someone with strong attention to detail, working knowledge of global PV standards (ICH, GVP, CIOMS), and experience operating in a fast-paced outsourced services environment.

Key Responsibilities

• Perform end-to-end clinical trials and post-marketing pharmacovigilance activities, including case intake, data entry, quality review, regulatory submission, and case reconciliation
• Perform targeted and systematic literature searches to identify reportable adverse events and relevant safety signals
• Assist in the drafting, review, and quality control of aggregate safety reports such as PSURs, PBRERs, and DSURs, as well as risk management documentation (e.g., RMPs, aRMMs)
• Contribute to the development, periodic review, and maintenance of pharmacovigilance Standard Operating Procedures (SOPs) and related work instructions
• Support inspection and audit readiness by participating in internal/external audits and following up on Corrective and Preventive Actions (CAPAs)
• Deliver or support PV-related training for both client-facing teams and internal staff members
• Maintain proactive and professional communication with clients and internal stakeholders regarding project timelines, safety deliverables, and compliance expectations
• Ensure all activities are performed in accordance with client-specific procedures and iPharmX quality and compliance standards
• Monitor and meet key performance indicators (KPIs) and coordinate closely with the Project Manager to ensure timely and accurate deliverables
• Manage translation activities as required

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, Nursing, or related discipline
• Minimum 3 years of hands-on pharmacovigilance experience in a CRO, pharmaceutical, or biotechnology environment
• In-depth understanding of global PV regulations and guidance (EMA GVP, FDA, ICH), with hands-on pharmacovigilance experience with the Drug Administration of Vietnam (DAV) and National DI & ADR Centre.
• Practical working knowledge of reporting requirements and processes through GVP adherence under DAV and National DI & ADR Centre.
• Fluency in English and Vietnamese (written and spoken)

Pharmacovigilance Specialist

About the Role

As a Pharmacovigilance Specialist, you will support all safety-related activities across clinical development and post-marketing phases on behalf of our clients. You will be responsible for Individual Case Safety Report (ICSR) management, Clinical Trial submissions, literature review, aggregate report contributions and signal management support, ensuring compliance with the Thai Food and Drug Administration (Thai FDA). This is a hands-on role ideal for someone with strong attention to detail, working knowledge of global PV standards (ICH, GVP, CIOMS), and experience operating in a fast-paced outsourced services environment.

Key Responsibilities

• Perform end-to-end clinical trials and post-marketing pharmacovigilance activities, including case intake, data entry, quality review, regulatory submission, and case reconciliation
• Perform targeted and systematic literature searches to identify reportable adverse events and relevant safety signals
• Assist in the drafting, review, and quality control of aggregate safety reports such as PSURs, PBRERs, and DSURs, as well as risk management documentation (e.g., RMPs, aRMMs)
• Contribute to the development, periodic review, and maintenance of pharmacovigilance Standard Operating Procedures (SOPs) and related work instructions
• Support inspection and audit readiness by participating in internal/external audits and following up on Corrective and Preventive Actions (CAPAs)
• Deliver or support PV-related training for both client-facing teams and internal staff members
• Maintain proactive and professional communication with clients and internal stakeholders regarding project timelines, safety deliverables, and compliance expectations
• Ensure all activities are performed in accordance with client-specific procedures and iPharmX quality and compliance standards
• Monitor and meet key performance indicators (KPIs) and coordinate closely with the Project Manager to ensure timely and accurate deliverables
• Manage translation activities as required

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, Nursing, or related discipline
• Minimum 3 years of hands-on pharmacovigilance experience in a CRO, pharmaceutical, or biotechnology environment
• In-depth understanding of global PV regulations and guidance (EMA GVP, FDA, ICH), with hands-on pharmacovigilance experience with the Thai Food and Drug Administration (Thai FDA)
• Practical working knowledge of reporting requirements and processes through GVP adherence under Thai FDA
• Fluency in English and Thai (written and spoken)

Pharmacovigilance Specialist

About the Role

As a Pharmacovigilance Specialist, you will support all safety-related activities across clinical development and post-marketing phases on behalf of our clients. You will be responsible for Individual Case Safety Report (ICSR) management, Clinical Trial submissions, literature review, aggregate report contributions and signal management support, ensuring compliance with the National Medical Products Administration (NMPA), China. This is a hands-on role ideal for someone with strong attention to detail, working knowledge of global PV standards (ICH, GVP, CIOMS), and experience operating in a fast-paced outsourced services environment.

Key Responsibilities

• Perform end-to-end clinical trials and post-marketing pharmacovigilance activities, including case intake, data entry, quality review, regulatory submission, and case reconciliation
• Perform targeted and systematic literature searches to identify reportable adverse events and relevant safety signals
• Assist in the drafting, review, and quality control of aggregate safety reports such as PSURs, PBRERs, and DSURs, as well as risk management documentation (e.g., RMPs, aRMMs)
• Contribute to the development, periodic review, and maintenance of pharmacovigilance Standard Operating Procedures (SOPs) and related work instructions
• Support inspection and audit readiness by participating in internal/external audits and following up on Corrective and Preventive Actions (CAPAs)
• Deliver or support PV-related training for both client-facing teams and internal staff members
• Maintain proactive and professional communication with clients and internal stakeholders regarding project timelines, safety deliverables, and compliance expectations
• Ensure all activities are performed in accordance with client-specific procedures and iPharmX quality and compliance standards
• Monitor and meet key performance indicators (KPIs) and coordinate closely with the Project Manager to ensure timely and accurate deliverables
• Manage translation activities as required

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, Nursing, or related discipline
• Minimum 3 years of hands-on pharmacovigilance experience in a CRO, pharmaceutical, or biotechnology environment
• In-depth understanding of global PV regulations and guidance (EMA GVP, FDA, ICH), with hands-on pharmacovigilance experience with the National Medical Products Administration (NMPA), China
• Practical working knowledge of reporting requirements and processes through China's national safety monitoring systems and expectations under NMPA PV regulations
• Fluent in English and Mandarin (Simplified Chinese)

Pharmacovigilance Specialist

About the Role

As a Pharmacovigilance Specialist, you will support all safety-related activities across clinical development and post-marketing phases on behalf of our clients. You will be responsible for Individual Case Safety Report (ICSR) management, Clinical Trial submissions, literature review, aggregate report contributions and signal management support, ensuring compliance with the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. This is a hands-on role ideal for someone with strong attention to detail, working knowledge of global PV standards (ICH, GVP, CIOMS), and experience operating in a fast-paced outsourced services environment.

Key Responsibilities

• Perform end-to-end clinical trials and post-marketing pharmacovigilance activities, including case intake, data entry, quality review, regulatory submission, and case reconciliation
• Perform targeted and systematic literature searches to identify reportable adverse events and relevant safety signals
• Assist in the drafting, review, and quality control of aggregate safety reports such as PSURs, PBRERs, and DSURs, as well as risk management documentation (e.g., RMPs, aRMMs)
• Contribute to the development, periodic review, and maintenance of pharmacovigilance Standard Operating Procedures (SOPs) and related work instructions
• Support inspection and audit readiness by participating in internal/external audits and following up on Corrective and Preventive Actions (CAPAs)
• Deliver or support PV-related training for both client-facing teams and internal staff members
• Maintain proactive and professional communication with clients and internal stakeholders regarding project timelines, safety deliverables, and compliance expectations
• Ensure all activities are performed in accordance with client-specific procedures and iPharmX quality and compliance standards
• Monitor and meet key performance indicators (KPIs) and coordinate closely with the Project Manager to ensure timely and accurate deliverables
• Manage translation activities as required

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, Nursing, or related discipline
• Minimum 3 years of hands-on pharmacovigilance experience in a CRO, pharmaceutical, or biotechnology environment
• In-depth understanding of global PV regulations and guidance (EMA GVP, FDA, ICH), with hands-on pharmacovigilance experience with the Pharmaceuticals and Medical Devices Agency (PMDA), Japan
• Practical working knowledge of reporting requirements and processes through the PMDA Safety Reporting systems and electronic submission pathways (e.g., JP-ICSRS), including periodic reports and expedited reporting
• Fluent in English and Japanese

Pharmacovigilance Intern

About the Role

We are seeking motivated students or recent graduates for a Pharmacovigilance Internship in Singapore. This full-time internship offers hands-on experience in drug safety monitoring, adverse event reporting, and regulatory compliance. Interns will work closely with our experienced team to support clinical trial and post-marketing pharmacovigilance activities, ensuring compliance with the Health Sciences Authority (HSA), Singapore regulations.

Key Responsibilities

• Assist in adverse event case processing and Individual Case Safety Report (ICSR) data entry
• Support literature monitoring and search activities to identify reportable safety information
• Help maintain pharmacovigilance databases and documentation systems
• Participate in the preparation of safety reports and regulatory submissions
• Assist in quality control checks and case reconciliation activities
• Support the documentation and filing of pharmacovigilance records
• Learn and apply global PV standards (ICH, GVP, CIOMS) under supervision
• Participate in team meetings and training sessions
• Collaborate with team members on various pharmacovigilance projects
• Assist with administrative tasks related to drug safety operations

Qualifications

• Currently pursuing or recently completed a Bachelor's or Master's degree in Pharmacy, Biomedical Sciences, Nursing, Life Sciences, or related healthcare discipline
• Strong interest in drug safety, pharmacovigilance, and regulatory affairs
• Understanding of Singapore's Health Sciences Authority (HSA) regulations and guidelines (or willingness to learn)
• Excellent attention to detail and organizational skills
• Proficient in English (written and spoken); knowledge of additional Asian languages is a plus