Senior Drug Safety Analyst (Remote - Bali, Indonesia)

Global Pharmaceutical Solutions · 📍 Bali, Indonesia · Diposting 2026-10-09
FULL_TIME⭐ TERVERIFIKASI
IDR 90,000,000 - 105,000,000
Global Pharmaceutical Solutions is seeking a highly skilled and experienced Senior Drug Safety Analyst to join our team. In this remote position, you will be responsible for ensuring the safety and efficacy of our pharmaceutical products. You will work closely with our regulatory affairs team to ensure compliance with international safety standards. This is an exciting opportunity to make a significant impact on public health while working for a leading global pharmaceutical company.

📋 Tanggung Jawab Pekerjaan

Conducting thorough analyses of drug safety data to identify potential risks and trends.,Collaborating with regulatory affairs team to ensure compliance with international safety standards.,Preparing and submitting regulatory submissions for drug safety, including adverse event reports and pharmacovigilance reports.,Monitoring and reporting on drug safety issues, including adverse drug reactions and safety concerns.,Conducting root cause analyses for drug safety incidents to identify underlying causes and implement corrective actions.,Providing expert advice and guidance to internal teams on drug safety issues and best practices.,Participating in drug safety audits and inspections to ensure compliance with regulatory requirements.

🎓 Kualifikasi & Syarat

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, or a related field.,Master's degree or PhD in a relevant field is a plus.,5-7 years of experience in drug safety, regulatory affairs, or a related field.,Strong knowledge of international drug safety regulations, including ICH E2B(R3) and WHO guidelines.,Proficiency in data analysis tools and statistical software, such as SAS, R, or Python.,Excellent written and verbal communication skills in English.,Strong problem-solving and analytical skills.,Ability to work independently and as part of a team in a fast-paced environment.

🛠️ Keahlian

Regulatory affairsDrug safetyData analysisStatistical softwareRegulatory complianceRoot cause analysisAdverse event reportingPharmacovigilance
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