Pharmacovigilance Specialist
4 settimane fa
About the Role
Tfs Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.
We are seeking a highly skilled Pharmacovigilance Officer to join our SRS/FSP team, 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
Requirements
- 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
About Us
Tfs Healthscience has been a leading global Contract Research Organization (CRO) for over 27 years, building solution-driven teams working towards a healthier future.
We deliver 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.
-
Pharmacovigilance Specialist
4 settimane fa
Roma, Lazio, Italia Tn Italy A tempo pienoJob Title: Pharmacovigilance SpecialistJob Summary:We are seeking a highly skilled Pharmacovigilance Specialist to join our team at TFS. As a Pharmacovigilance Specialist, you will be responsible for handling and processing adverse event reports, conducting literature searches, and contributing to the development of safety documents.Key...
-
Global Pharmacovigilance Safety Coordinator
4 settimane fa
Roma, Lazio, Italia Https:Www.Energyjobline.ComSitemap A tempo pienoWe are seeking a skilled Pharmacovigilance Safety Reports Specialist to join our team at Angelini Pharma. As a key member of our pharmacovigilance team, you will be responsible for ensuring the accuracy and completeness of safety reports for our medicinal products and medical devices.The ideal candidate will have a strong background in pharmacovigilance,...
-
Pharmacovigilance Specialist
4 settimane fa
Roma, Lazio, Italia Https:Www.Energyjobline.ComSitemap A tempo pienoKey Responsibilities:As a Pharmacovigilance Specialist, you will be responsible for handling SAEs in clinical trials and spontaneous reports from the market, ensuring collection, assessment, and entry into the safety database in accordance with TFS/clients' SOPs and existing demands of the authorities.Responsibilities:Review and approval of processed cases...
-
Pharmacovigilance Specialist
4 settimane fa
Roma, Lazio, Italia Tn Italy A tempo pienoJob Title: Pharmacovigilance OfficerAt TFS, we are seeking a highly skilled Pharmacovigilance Officer to join our team. As a key member of our Safety team, you will be responsible for ensuring the safe use of our clients' products.Key Responsibilities:Handling of Serious Adverse Events (SAEs) in clinical trials and spontaneous reports from the marketReview...
-
Roma, Lazio, Italia Angelini Pharma A tempo pienoJob SummaryWe are seeking a highly skilled Pharmacovigilance Safety Specialist to join our team at Angelini Pharma. The successful candidate will be responsible for coordinating the preparation and submission of safety reports for medicinal products and medical devices across various geographies.Main ResponsibilitiesDocument Preparation: Schedule and...
-
Global Pharmacovigilance Safety Coordinator
4 settimane fa
Roma, Lazio, Italia Angelini Pharma A tempo pienoWe are seeking a skilled Pharmacovigilance Safety Reports Specialist to join our team at Angelini Pharma.Main Responsibilities:Document Preparation: Schedule and maintain the planning of all safety reports for medicinal products and medical devices across different geographies where Angelini is present.Coordination: Ensure proper coordination of safety...
-
Medical Oncology Specialist
1 mese fa
Roma, Lazio, Italia AbbVie A tempo pienoJob DescriptionAs a Medical Oncology Specialist at AbbVie, you will play a crucial role in driving medical activities to support the Brand Strategy and integrate it into the Brand Plan. Your expertise in oncology will be essential in warranting the medical know-how of the Affiliate regarding the relevant therapeutic areas of assigned products.Key...
-
Medical Oncology Specialist
1 mese fa
Roma, Lazio, Italia AbbVie A tempo pienoJob SummaryWe are seeking a highly skilled Medical Oncology Specialist to join our team at AbbVie. As a Medical Oncology Specialist, you will be responsible for providing medical expertise and support to our Affiliate in the areas of oncology and related therapeutic areas.Key Responsibilities:Provide medical know-how and support to the Affiliate regarding...
-
Regulatory Affairs Specialist
6 mesi fa
Roma, Italia PrimeVigilance A tempo pienoCompany Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...
-
Country Quality Assurance Specialist
6 mesi fa
Roma, Italia BAXTER A tempo pieno**This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...
-
Quality Specialist
5 mesi fa
Roma, Italia Novo Nordisk A tempo pienoQuality Specialist **Category**:Quality**Location**:Roma, Lazio, IT- Passionate about ensuring quality and compliance in a global healthcare company? Look no further! An exciting opportunity awaits you as a Quality Specialist in our Rome office, Italy. Join our team and help us provide life-changing care to those in need.**The Position** - In this position...
-
Product Specialist Catania
5 mesi fa
Roma, Italia Abbott Laboratories A tempo pieno**The Product Specialist works Promoting and obtaining acceptance and approval of the products**, in order to **maximize prescriptions **and achieve the assigned goals. **Operating in compliance **with the laws in force and the Group Code of Conduct. He / she need to be able to Identify and develop relationships with HCPs (MD and other Health Care...
-
Medical Advisor Oncology
5 mesi fa
Roma, Italia AbbVie A tempo pieno**Company Description** **Job Description** Key Responsibilities**: - Warrant the medical know-how of the Affiliate regarding the relevant therapeutic areas of assigned products (including AbbVie products, competitors and general knowledge of specific diseases). - Drive Medical activities to support the Brand Strategy and integrate it into the Brand Plan -...
-
Country QA
6 mesi fa
Roma, Italia BAXTER A tempo pieno**This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...