Drug Safety Officer

2 settimane fa

Roma, Lazio, Italia Tfs Healthscience A tempo pieno

**Pharmacovigilance Officer - Single sponsor position (French multinational company)**
**About this role**
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.
- As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader in different Therapeutic Areas_
**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
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 years of experience in a Pharmacovigilance officer role
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
**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 27 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.

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