Safety Associate (1year contract, 0.5FTE)

Job OverviewReview, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.Essential Functions• To Prioritize and complete the assigned trainings on time.• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information• determining initial/update status of incoming events• database entry• coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.• Ensure to meet quality standards per project requirements.• Ensure to meet productivity and delivery standards per project requirements.• To ensure compliance to all project related processes and activities.• Creating, maintaining and tracking cases as applicable to the project plan.• Identify quality problems, if any, and bring them to the attention of a senior team member.• To demonstrate problem solving capabilities.• To mentor new teams members, if assigned by the Manager.• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.• 100% compliance towards all people practices and processes• Perform other duties as assigned.

Qualification

• 1년 계약직, 주 20시간 근무• 신입 가능• 화장품 이상 보고 또는 이상 반응 보고 경험자 선호 • Clinical Research experience would be an advantage