job description
Join Roche, a global leader in healthcare innovation, as a Regional Center Partner (Pharmacovigilance) on a 1-year contract based in Bali, Indonesia. This pivotal role supports our Regional Center activities, ensuring compliance with internal processes and local/international regulatory standards in pharmacovigilance (PV). Youâll collaborate with cross-functional teams to monitor drug safety, report adverse events, and contribute to Rocheâs mission of delivering life-changing medicines.
As a key member of our pharmacovigilance team, youâll bridge regional operations with global standards, playing a critical role in safeguarding patient safety. This contract position offers flexibility, professional growth, and the opportunity to work with cutting-edge healthcare solutions in a dynamic, remote-first environment. Ideal for pharmacovigilance professionals seeking a challenging yet rewarding role with one of the worldâs most respected pharmaceutical companies.
Roche values diversity, inclusion, and work-life balance. This role is perfect for candidates in Bali looking to advance their career in pharmacovigilance while enjoying the islandâs vibrant culture and lifestyle.
Responsibility
- Support Regional Center pharmacovigilance (PV) activities in alignment with Rocheâs internal processes and global regulatory requirements.
- Monitor, collect, and report adverse drug reactions (ADRs) and safety data from regional sources, ensuring timely and accurate submission.
- Collaborate with local and international teams to assess drug safety signals and contribute to risk management plans.
- Maintain compliance with ICH-GCP, FDA, EMA, and other relevant pharmacovigilance guidelines and regulations.
- Assist in the preparation and review of pharmacovigilance documentation, including periodic safety update reports (PSURs) and risk evaluation reports.
- Provide training and guidance to regional stakeholders on pharmacovigilance processes and reporting standards.
- Participate in audits and inspections, ensuring readiness for regulatory reviews and compliance checks.
- Contribute to continuous improvement initiatives to enhance pharmacovigilance systems and workflows.
Qualifications
- Bachelorâs degree in Pharmacy, Medicine, Life Sciences, or a related field (Masterâs or advanced degree preferred).
- Minimum 3 years of experience in pharmacovigilance (PV), drug safety, or regulatory affairs within the pharmaceutical or biotech industry.
- Strong knowledge of ICH-GCP, FDA, EMA, and local pharmacovigilance regulations (e.g., BPOM in Indonesia).
- Experience with safety databases (e.g., Argus, ARISg, or similar) and pharmacovigilance reporting systems.
- Excellent analytical skills with the ability to interpret complex safety data and identify trends.
- Proficient in English (written and verbal); additional regional languages (e.g., Bahasa Indonesia) are a plus.
- Detail-oriented with strong organizational and time-management skills to meet tight deadlines.
- Ability to work independently in a remote setting while collaborating effectively with global teams.