Patient Safety Associate

2 weeks ago

Philippines Groupe ProductLife Full time
Patient Safety Associate (Korean Language Fluency)

Philippines

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Life Cycle

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Safety and Vigilance

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Permanent contract

ProductLife Group is looking for a Patient Safety Associate (Fluent in Korean) to have responsibility for allocated tasks within the pharmacovigilance activities delivered by the platform.

The Patient Safety Associate is responsible for assisting in the day-to-day delivery of pharmacovigilance and safety related projects, including processing safety information received by, or requiring action on behalf of clients. Projects include patient safety, support and monitoring programs and involve devices, prescription, OTC and consumer goods.

Role Responsibilities –

• Act as part of PS & RM Team in line with the scope of the project in order to meet project outcomes and deliverables ensuring compliance.

• Work within the systems and processes designed to meet Good Pharmacovigilance (GPV) practice.

• Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures.

• Evaluate adverse events & follow up reports received from various channels and assesses seriousness based on criteria.

• Process & report safety data as per SOP’s and client instructions in order to maintain client and regulatory compliance.

• Maintain the integrity of client safety data registered into GxP databases and associated paper-based systems.

• Prepare project reports and tracks agreed KPI’s in order to meet project deliverables.

• Participate in the provision of after hour’s safety related telephone services as required by the project scope.

• Participate in internal and external audits.

• Act as a subject matter expert both internally and externally.

• Train and mentor other team members.

• Proactive contribution to improving business processes.

• Assist the Pharmacovigilance Manager as requested.

Qualifications / Experience / Skills –

• Health Science degree or equivalent

• At least 12 months’ experience in a drug safety or equivalent role in a highly regulated industry e.g., pharmaceutical or devices

• Good working knowledge of the regulatory requirements for managing and reporting adverse events in Australia and New Zealand

• Understanding of the applicable EU and APAC requirements

• Highly developed service, communication, organizational and problem-solving skills

• High level of attention to detail and computer literacy with experience in safety databases

• Practical experience in SOP writing and document management

English language proficiency is a must.

Must be able to read and write in Korean proficiently, especially scientific language.

Minimal speaking interactions with client but spoken proficiency would be a nice to have.

Work Hours

Mondays to Fridays

  • 8am to 5pm (Philippine time)
Patient Safety Associate (Korean Language Fluency) #J-18808-Ljbffr

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