Pharmacovigilance - Local Safety Officer

4 days ago

Jakarta, Indonesia PERSOLKELLY Recruitment Indonesia Full time

Persyaratan
- Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.
- Min. 1 years of relevant pharmacovigilance experience
- Sound knowledge of general medicine or pharmacy and clinical practice, scientific/life-science background, medicinal knowledge preferred; proficiency in Medical terminology (local languages).
- Proven ability to organize workflow activities and manage multiple critical issues.
- Computer literate with basic knowledge of GMS database systems.
- Good verbal and written communication skills, fluency in local language(s) and English language required.
- Demonstrable knowledge of all local Pharmacovigilance requirements and of Global aspects of drug safety.

Tanggung Jawab
- Act as Local Nominated Person (including back-up nominated person)
- Maintain up-to-date knowledge on Pharmacovigilance requirements in Indonesia, including reporting requirements (for all applicable product classes in the country) and collaborating with the global team to implement process changes required on identification of new requirements.
- Maintaining oversight on day-to-day adverse events inbound and outbound reporting as applicable in the given country
- Receiving and supporting the responses to safety-related Health Authority queries
- Collaborating with global and local teams to notify local Health Authorities of any safety issues including SSI/ESI and signals
- Providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files and collaborating with the global team to meet requirements for local PSMFs, if applicable
- Collaborating with the local and global teams to ensure PV compliance of local company sponsored programs and research activities
- Ensuring the provision of information to global teams for local activities compliance with individual cases and periodic safety reporting, implementation of risk management plans, and key performance indicators related to overseeing local implementation of any other specific risk management activities
- Supporting local Health Authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable
- Recording self-identified non-conformances and collaborating with the global team to investigate non-conformances and develop and implement effective CAPAs
- Maintaining local procedures where applicable and assessing the impact of changes to the global procedure to local procedures
- Ensuring current knowledge on all relevant company procedures
- Training and ensuring document management and archiving

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