Drug Safety Officer

Lisbon - Portugal

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

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 US UK Poland Portugal or Sweden.

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. Youll be joining a team that values collaboration innovation and making a difference in the lives of patients

A Bit More About Us

Our journey began over 29 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 800 professionals TFS delivers tailored clinical research services in more than 40 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.