Senior Drug Safety Officer - Deputy QPPV

Senior Drug Safety Officer - Deputy QPPV

TFS HealthScience

Remote, Europe

About this role

The Senior Drug Safety Officer is part of the Project Delivery organization and will work on handling of drug safety/vigilance issues according to company policies, SOPs and regulatory requirements.

Responsibilities

• Manage the handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the TFS/clients’ SOPs and existing demands of the authorities;
• Review and approval of processed cases and AE/SAE reconciliation;
• Coding of adverse event, medical history and concomitant medication according to MedDRA and WHO-Drug Dictionary;
• QC and approval of coding of adverse event, medical history and concomitant medication;
• Review and write the safety section in clinical study protocols;
• Review of clinical trial reports/IBs from a safety perspective;
• Write the safety parts in the PSUR/PBRER, DSURs, IND, NDA and other safety documents;
• Literature search;
• Electronic reporting to EudraVigilance;
• Responsible for plans/instructions and SOPs for post approval surveillance;
• Updating of templates for safety handling in specific studies/projects according to relevant SOPs;
• Act as a Project Lead for Safety-only projects;
• Overlook that assigned projects and tasks in the unit are done in accordance with current routines, methods, SOPs (TFS or client´s) and existing demands of the authorities;
• Participate in relevant meetings. Forward information to relevant members of the department or study team members;
• Initiate and lead internal improvement projects with other relevant departments;
• Actively contribute to the organization and development of routines to enhance the work at TFS;
• Responsible for safety database life cycle including validation, migration, database setup processes, system retirement, periodic review, change management and user acceptance test writing with respect to drug safety regulations, SOPs. Authoring corresponding documentation;
• Being well-informed and updated on laws, directives and guidelines concerning handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues;
• Education and supervision of new Drug Safety personnel;
• Participate in marketing activities.

Qualifications

• Bachelor’s Degree, preferably in life science or nursing; or equivalent;
• 3-5 years of relevant experience working as a Drug Safety Officer;
• Able to work in a fast-paced environment with changing priorities;
• Understand the medical terminology and science associated with the assigned drugs and therapeutic areas;
• Understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs;
• Ability to work independently as well as in a team matrix organization with little or no supervision;
• Excellent written and verbal communication skills;
• Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus.

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