Join us in our mission to INVENT the future. Let¡¯s be part of our team of dedicated, energetic individuals who are committed to be the most trusted supplier of pharmaceuticals and health products worldwide. Apply now as Clinical Research Manager to be based in South Korea.
Our Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
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Hiring position
PV Specialist (Temporary) 1Year
Key Responsibilities
-Responsible for execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation
-Responsible for day-to-day adverse events case management including case intake and follow-up activities in accordance with PV procedures and country regulations.
-Responsible for the intake of cases received from the designated point of contact, Vendors, and Business Partners for Individual case safety reports (ICSRs) including tracking and translation to English and forwarding of information to the Data Management Center. He/she also perform ICSR acknowledgments and reconciliation activities.
-Performs reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations
-Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements
-Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
-Supports local PV audits and inspections including readiness activities and supports audits of business partners/vendors as directed by their manager.
-Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
-Provides training to local PV staff, company personnel, distributors, vendors, and business partners as instructed by their manager.
-May be assigned responsible for ensuring PV language is included in local agreements and ensuring maintenance of BDLM with respect to local and regional contracts.
-Proactively identifies procedural gaps and challenges and implements solutions in collaboration with affected stakeholders.
-Liaises with the local business units to keep them apprised of safety activities and provide input on strategic decisions (i.e., new clinical trials, product launches, etc.) with Management oversight.
-May be assigned responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally with oversight by their manager.
-May be assigned responsible for ensuring appropriate implementation and oversight of Post-Approval Safety Monitoring Program (PSMP) locally with oversight by their manager.
Qualifications
¡¤ Background requirement: Health, life science or medical science degree (pharmacist preferred)
¡¤ Minimum1 years of pharmaceutical industry experience preferred
¡¤ Functional Knowledge: Awareness of pharmacovigilance concepts, principles, practice & standards, knowledge of pharmacovigilance regulation and GCP
¡¤ Skills: excellent written &spoken English, communication skill, time management skill, sense of urgency, compliance mindset & computer skill
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https://msd.wd5.myworkdayjobs.com/SearchJobs/job/KOR---Seoul---Seoul-Square/PV-Specialist_R101844
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