Drug Safety Officer

TFS HealthScience; Southampton; Hybride; GBP 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Competitive compensation

Comprehensive benefits

Résumé du poste

TFS HealthScience is seeking a Drug Safety Officer for a home-based role across multiple European countries including the UK. The position sits within the CDS Ophthalmology Drug Safety team and focuses on handling SAE/vigilance issues in compliance with SOPs and regulatory requirements.

The role may involve leading safety-only projects and cross-functional collaboration. Responsibilities include coding adverse events, safety writing for PSURs/DSURs/INDs, electronic reporting to EudraVigilance,

Qualifications

• 5 years of relevant experience.
• Understanding of Good Clinical Practice (GCP) regulations, ICH guidelines, pharmacovigilance legislation and internal SOPs.
• Excellent written and verbal communication skills.
• Ability to work independently as well as in a matrix organization with limited supervision.

Responsabilités

• Handle SAE in clinical trials and spontaneous reports from the market, ensuring collection, assessment and entry into the safety database per SOPs and regulatory demands.
• Review and approve processed cases and AE/SAE reconciliation.
• Code adverse events, medical history and concomitant medication per MedDRA and WHO-Drug Dictionary; QC and approval of coding.
• Review and write safety sections in CSRs, DSURs, PSURs, INDs and NDAs; update literature searches and safety documents.
• Provide internal support to other departments and contribute to safety-related SOPs and templates.

Description du poste

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Drug Safety Officer - home based in Portugal, Poland, Spain, UK or Sweden (hybrid).

As part of our CDS Ophthalmology Drug Safety team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The 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.

Key Responsibilities

• 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
• Contribute to plans/instructions and SOPs for post approval surveillance
• Updating of templates for safety handling in specific studies/projects according to relevant SOPs
• May act as a Project Lead for Safety-only projects
• Participate in relevant meetings. Forward information to relevant members of the department or study team members
• Provide internal support to other relevant departments
• Involved in improvement projects with other relevant departments
• Actively contribute to the organization and development of routines to enhance the work at TFS
• Validation of computer applications specific for the department with respect to drug safety requirements
• 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

• 5 years of relevant experience
• 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

What We Offer

We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

For candidates based in Spain - TFS is committed to equal opportunities. All our vacancies are open to people with disabilities, in accordance with the General Law on the Rights of Persons with Disabilities (Royal Legislative Decree 1/2013).

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.