Specialist - Clinical Safety Operations

Job Description

The role of the Specialist - Clinical Safety Operations is to contribute to effective and efficient proactive safety strategies for the assigned processes and delivery of operational clinical safety aspects. This includes the provision of specialist guidance to concerned Global Drug Safety functions and other functions within the company, as well as vendors for clinical safety operational tasks.In addition, the Specialist - Clinical Safety Operations assist Expert Clinical Safety Operations and Clinical Safety Manager for the development, optimization, implementation, and documentation of appropriate processes to ensure pharmacovigilance compliance in the area of responsibility. Support in defining process KPls, implement, monitor and communicate performance and support in developing solutions for continuous improvements.The Specialist - Clinical Safety Operations is responsible and accountable for:

• Support to Clinical Safety Operations (CSO) and Management
• Standard operating procedure (SOPs), Working Instructions (WI) reviews, inputs, knowledge and understanding.
• Assist to defining and implementing of clinical trial safety-related activities in the Alliance with relevant partners/service providers of the company and alignment of guidelines and processes related to clinical trial safety management with existing GDS processes.
• Collaborate for Safety Management Plan (SMP), including review and oversight.
• Assist in maintenance of Reference Safety Information (RSI)
• Coordinate activities for Safety Monitoring Committee (SMC)/ Data Monitoring Committee (DMC).
• Perform Serious Adverse Event (SAE) and ISS reconciliation
• Support query management within Common Communication Module (CCM tool)
• Act as a subject matter expert (SME) for COMPASS database.
• Assist Electronic Trial Master File (eTMF) safety relevant core document review
• Coordiante Trial oversight plan (TOP) for safety relevant sections
• Contribute to improvement of routine pharmacovigilance activities throughout the process lifecycle.
• Liaise between internal/ external stakeholders as needed.
• Contribute during audits and inspections as assigned. Assist Expert Clinical Safety Operations for completion of CAPA plans.
• Mentor developing specialists, less experienced or newer staff members.
• May provide oversight role on operational and collaborative tasks as directed by manager or Head of Clinical Safety Operations.
• Participate in team meetings.
• Contribute to achievement of departmental goals.
• Ensure all required training is executed within stipulated time period.

Who you are:Education

• Bachelor s Degree or education equivalent in a Scientific or Healthcare discipline
• Experience in Healthcare, pharmacovigilance, safety publishing, clinical development, or clinical research is an advantage
• Fluent in written and spoken English.

Experience

• Minimum 3 years of professional experience in Drug Safety/Pharmacovigilance of Clinical Trials
• Basic knowledge of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines.
• Understanding of worldwide regulations relevant to the safety of drugs in development and post-authorization
• Willingness and aptitude to learn new skills across Clinical Safety Operations
• Proven ability to meet strict deadlines;
• Proven ability to follow instructions/ guidelines.
• Good understanding of operational metrics and productivity.
• Excellent attention to detail and accuracy and maintain consistently high-quality standards.
• Ability to be flexible and receptive to changing process demands.
• Ability to establish effective working relationships with coworkers, managers, partners and vendors.
• Excellent communication skills in an international environment.
• Intercultural experience through successful collaboration in matrix teams.

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Keyskills :
good clinical practicedrug safetyclinical trialsdata monitoringquery managementclinical researchsafety managementsafety monitoring