Drug Safety Officer

Overview:
TFS HealthScience is excited to be expanding our SRS
** **team and we are looking for an experienced, highly motivated Drug Safety Officer who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.

Together we make a difference.

TFS HealthScience is looking for a Drug Safety Officer hybrid-based in Barcelona. This role will sit embedded within one of our prestigious clients who promotes rapid career development

**What can we offer you?**

A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.

**Benefits include**:
Lunch allowance

Health Insurance

Flexible working times

Home allowance

Flexible remuneration

**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 perspectiveWrite 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

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

2-3 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
- TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the _
- privacy notice_
- for further details._
- TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits._