Senior Drug Safety Officer - Temporary contract 1 year

About this role

TFSHealthScience is a leading global midsize Contract Research Organization(CRO) that partners with biotechnology and pharmaceutical companies throughouttheir entire clinical development journey. Our expertise includes fullservicecapabilities resourcing and functional service (FSP) solutions.

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 toensure collection assessment and entering into the safety database in accordance with theTFS/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 MedDRAand WHODrug 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 Safetyonly projects

Overlook that assigned projects and tasks in the unit are done in accordance with currentroutines methods SOPs (TFS or clients) and existing demands of the authorities

Participate in relevant meetings. Forward information to relevant members of the department orstudy 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 setupprocesses system retirement periodic review change management and user acceptance testwriting with respect to drug safety regulations SOPs. Authoring corresponding documentation

Being wellinformed and updated on laws directives and guidelines concerning handling andreporting of SAEs in clinical trials and serious as well as nonserious events from the market(pharmacovigilance) and other safety issues.

Education and supervision of new Drug Safety personnel

Participate in marketing activities

Qualifications:

Bachelors Degree preferably in life science or nursing; or equivalent

35 years of relevant experience working as a Drug Safety Officer

Able to work in a fastpaced 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 27 years ago in Sweden in the city of Lund. As a fullservice global Contract Research Organization (CRO) we build solutiondriven 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 decisionmaking 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.