Senior Drug Safety Officer

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 Senior Drug Safety Officer - home / office based in Israel.

About This Role

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

The Senior Drug Safety Officer will work on handling of drug safety/vigilance issues according to company policies, SOPs and regulatory requirements.

Key Responsibilities

• Manage the 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
• 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 Safety-only projects
• Overlook that assigned projects and tasks in the unit are done in accordance with current routines, methods, SOPs (TFS or client´s) and existing demands of the authorities
• Participate in relevant meetings. Forward information to relevant members of the department or study team members
  
  

Qualifications

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• 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

A Bit More About Us

Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make 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 organization.

#Together we make a difference