Drug Safety Officer

TFS HealthScience•Askersund, United Kingdom

1d•Hybrid

About The Position

TFS HealthScience is a global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout clinical development. The Drug Safety Officer is part of the Project Delivery organization and the CDS Ophthalmology Drug Safety team. The role handles drug safety and pharmacovigilance issues in accordance with company policies, standard operating procedures (SOPs), and regulatory requirements. It is home based in Portugal, Poland, Spain, the UK, or Sweden, with a hybrid arrangement indicated in the posting. The position covers safety case processing and review, coding and quality control, safety documentation for clinical studies and regulatory submissions, literature searches, and electronic reporting to EudraVigilance. The officer may lead safety-only projects, contribute to procedures and process improvement, validate department-specific computer applications, and help educate and supervise new Drug Safety personnel. The role also involves staying current with applicable safety laws and guidance, participating in meetings and marketing activities, and providing support to other departments.

Requirements

Five years of relevant experience.
Ability to work in a fast-paced environment with changing priorities.
Understanding of medical terminology and the science associated with assigned drugs and therapeutic areas.
Understanding of Good Clinical Practice regulations, ICH guidelines, pharmacovigilance legislation, and internal SOPs.
Ability to work independently and in a team matrix organization with little or no supervision.
Excellent written and verbal communication skills.
Proficiency with typical word-processing software.

Nice To Haves

Spreadsheet skills are desirable.
Presentation software skills are a plus.

Responsibilities

Handle serious adverse events (SAEs) in clinical trials and spontaneous reports from the market, ensuring collection, assessment, and entry into the safety database according to TFS and client SOPs and authority requirements.
Review and approve processed cases and perform adverse event (AE)/SAE reconciliation.
Code adverse events, medical history, and concomitant medication using MedDRA and the WHO-Drug Dictionary.
Perform quality control and approve coding of adverse events, medical history, and concomitant medication.
Review and write the safety section of clinical study protocols.
Review clinical trial reports and Investigator's Brochures (IBs) from a safety perspective.
Write safety sections of PSURs/PBRERs, DSURs, INDs, NDAs, and other safety documents.
Conduct literature searches.
Perform electronic reporting to EudraVigilance.
Contribute to plans, instructions, and SOPs for post-approval surveillance.
Update templates for safety handling in specific studies or projects according to relevant SOPs.
May act as Project Lead for safety-only projects.
Participate in relevant meetings and forward information to relevant department or study team members.
Provide internal support to other relevant departments.
Participate in improvement projects with other relevant departments.
Contribute to the organization and development of routines to improve work at TFS.
Validate department-specific computer applications with respect to drug safety requirements.
Stay informed about laws, directives, and guidelines concerning SAE handling and reporting in clinical trials, serious and non-serious market events, pharmacovigilance, and other safety issues.
Educate and supervise new Drug Safety personnel.
Participate in marketing activities.