Clinical & Drug Safety Associate

Otsuka people creating new products
for better health worldwide

is our philosophy that all Otsuka family globally know that they will be highly valued and encouraged to fulfill their potentials. We provide a welcoming, friendly and inspiring work environment that nurtures their growth and passion, as an individual and as part of a team, and stimulates their creativity that make us a unique and great place to work. The pharmaceutical company with our business includes manufacturing, trading, import and export of nutrition and pharmaceutical products. Total employees: Manufacturing 700 person, Head office (Sales and Business support) 200 person.

Job Responsibilities:

• Local Safety: 
  • Act as the Local Safety Officer, overseeing the management, evaluation, and timely reporting of safety information received from healthcare professionals and clinical trials/studies to global safety teams in accordance with company policies and regulatory requirements.
• Pharmacovigilance SOP Management: 
  • Serve as the SOP Coordinator for clinical and safety functions, managing the coordination, dissemination, and alignment of global, regional, and local SOPs.
  • Maintain, revise, and implement local Standard Operating Procedures (SOPs) for Pharmacovigilance as per global guidance. Conduct training sessions for relevant stakeholders to ensure compliance and awareness.
• Medical Information Services: 
  • Provide scientifically accurate, fair, and balanced responses to inquiries from healthcare professionals and consumers, based on the approved labeling and product inserts of marketed products.
  • Ensure up-to-date and accurate medical information of marketed products is maintained and distributed via the company’s internal file-sharing systems.
• Clinical Affairs Oversight: 
  • Oversee clinical research-related activities, including the systematic analysis and critical review of clinical, biomedical, and scientific reports with objectivity and scientific integrity.
• Safety Reporting: 
  • Collaborate closely with the Regulatory Affairs (RA) department to ensure timely and accurate reporting of adverse drug reactions (ADRs) to the Thai FDA under national pharmacovigilance and safety monitoring programs.
• Product Quality Complaints (PQC)/ Product Information Committee(PIC) : 
  • Support and coordinate Product Quality Complaint (PQC) activities to ensure appropriate safety evaluations and documentation, in alignment with internal and regulatory standards.
  • Be a member of the Product Information Committee, responsible for managing the review, approval, and archiving of promotional materials (PMs) to ensure scientific accuracy and regulatory compliance.

Qualifications & Competencies:

• Bachelor’s degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related scientific field.
• Proven experience in Clinical Research, Pharmacovigilance, Drug Safety within the healthcare or pharmaceutical industry.
• Minimum 2–3 years in a managerial or leadership role, overseeing clinical or safety operations.
• Good knowledge of Drug Safety Management, Good Clinical Practice (GCP), global pharmacovigilance (PV) regulatory guidelines, and clinical trial procedures.
• Excellent interpersonal and communication skills, with the ability to work effectively across cross-functional teams and liaise with regulatory authorities.
• Strong analytical, problem-solving, and decision-making abilities.
• Highly organized, proactive, and able to manage multiple priorities.
• Proficient in English, with a TOEIC score of 700 or higher.
• GCP and Pharmacovigilance training certifications are preferred.