[서초구] 외국계 제약사 Drug Safety(약학과 졸업생/약사) 채용

* 모집분야 포지션명 : DS Associate (Drug Safety)

* 업무내용 : 영문 Job Description

[Core safety activities]
-Responsible for day-to-day adverse event case management  into the safety database and relevant health authorities
-Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country
-Responsible for establishment of safety reporting process including pharmacovigilance agreement with partner company, local studies including Roche sponsored and investigator initiated and program including market research, patient support program and etc.
-Responsible for the reconciliation of adverse events reports received from other Roche operating units (e.g., Medical Information, etc.) and contractual partners, as applicable
-Ensure that safety query management is performed and maintain oversight of the Direct Healthcare Professional Communication (DHPC), Dear Investigator Letter (DIL) and To Whom It May Concern Letter (TWIMCL) process according to the global/local requirements
-Contribute to prepare the local RMP and provide input for its implementation in collaboration with relevant staff
-Provide safety-related information to global teams for the preparation of aggregate reports and ensure submission of aggregate reports to local regulatory authorities
-Provide input for training to relevant personnel in the affiliate, vendors and business partners
-Responsible for the filing, storage and archiving of safety-related data in accordance with Roche’s policies and local requirements.
-Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection.

[Other Local safety affiliate activities]
-Identify and communicate potential safety issues to Drug Safety Manager
-Maintains awareness of current prescribing information (eg. SmPC), investigator brochures and risk management plans to support product safety activities
-Ensures local quality assurance measures to maintain inspection readiness of local safety function
-Provides input into Safety or cross functional initiatives, if required, to share and develop best practice

-Maintains own current knowledge of and compliance with local safety regulations and global SOPs