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Urgent Hiring -Pharmacist - Malaysian citizen
RM 5,000 - RM 5,999 / month
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About the Role: We are seeking a dedicated and detail-oriented Pharmacist to join our Contact Research Organization (CRO) in Malaysia. The successful candidate will play a critical role in supporting clinical trials by ensuring the safe and efficient management of investigational products and compliance with regulatory standards. Key Responsibilities: 1. Prepare and submit applications to the NPRA for clinical trials, including CTIL license applications for the importation of new drugs intended for clinical trial purposes. 2. Investigational Product (IP) Management: - Oversee the receipt, storage, labeling, and distribution of investigational products. - Ensure proper documentation and traceability of IP handling in compliance with Good Clinical Practice (GCP) and study protocols. 3. Regulatory Compliance: - Ensure adherence to Malaysian regulatory requirements and international guidelines (e.g., FDA, EMA, ICH-GCP) in all pharmaceutical-related activities. - Maintain and update records for regulatory submissions and audit. 4. Clinical Trial Support: - Collaborate with the clinical team to develop and review study protocols, informed consent forms, and related documents. - Assist in preparing and reviewing pharmacy-related standard operating procedures (SOPs). 5. Quality Assurance: - Conduct audits of IP management processes to ensure consistency and accuracy. - Participate in inspections by regulatory authorities and sponsors, addressing any pharmacy-related findings 6. Training and Education: - Train clinical staff and investigators on the handling, administration, and documentation of investigational products. - Stay updated on advancements in clinical pharmacology and regulatory requirements. Requirements: • Bachelor’s Degree in Pharmacy (BPharm) or Doctor of Pharmacy (PharmD). • Registered and licensed as a Pharmacist in Malaysia. • Minimum of 3 years of experience preferably in clinical trials, research, or a related field. • Strong understanding of Good Clinical Practice (GCP) and local regulatory guidelines. • Exceptional organizational skills and attention to detail. • Effective communication and teamwork abilities. Preferred Qualifications: • Experience working in a Contact Research Research Organization or pharmaceutical industry (It's preferred but not essential). • Familiarity with investigational drug protocols and documentation requirements. • Certification in Good Clinical Practice (GCP) or Clinical Research