Medical & Scientific Specialist I

The biggest opportunity in the first research organization by Thai startups. Clinixir looking for outstanding candidates to be a part in building and driving CRO to grow globally.

Responsibilities

• Perform the following pharmacovigilance activities for clinical research projects in compliance with applicable regulations, guidelines, and company SOPs:
• Adverse event monitoring, Individual Case Safety Report (ICSR) processing, contribute to the preparation of aggregate safety reports, and support regulatory safety reporting to health authorities and ethics committees.
• Support DSMB and Medical Monitoring activities, including engagement with experts and serve as a point of contact
• Support safety database activities
• Perform medical coding
• Perform medical writing activities for clinical research projects, including real-world evidence (RWE) studies:
• Assist in the development of scientific materials such as protocols, ICFs, clinical study reports, and other medical information documents.
• Participate in the design and implementation of RWE studies, including protocol development and data collection methodologies.
• Assist in the preparation and review of scientific publications, including manuscripts, abstracts, and posters.
• Maintain complete and inspection-ready documentation and filing in the TMF
• Contribute to the development of educational materials and training modules for internal and external stakeholders.
• Collaborate with cross-functional teams to ensure alignment with regulatory standards and project timelines.
• Participate in the collection, organization, and analysis of real-world evidence (RWE) data for various projects.
• Support the coordination of medical communication strategies, including development of scientific slides and presentations.
• Engage in stakeholder interactions, including participation in scientific meetings, conferences, and advisory boards.
• Support internal quality improvement initiatives and contribute to SOP updates when required.

Qualifications

• Bachelor's degree in Pharmacy or a relevant field (e.g., sciences, medical sciences).
• At least 1 year of experience in medical or scientific roles or clinical research.
• Basic knowledge of pharmacovigilance, medical affairs, and regulatory compliance.
• Understanding of clinical trial documentation such as protocols, ICFs, CSRs, and safety reports
• Strong written and verbal communication, organizational, and interpersonal skills.
• Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.

Good Benefit

• Annual Leave 15 Days
• Birthday leave 1 Day
• Medical Insurance
• Provident Fund
• Annual health check with flu vaccination

Hybrid Work

Clinixir Office, Asia Centre Building (BTS Chongnonsi)