Global Pharmacovigilance Safety Coordinator
1 mese fa
We have an opportunity for a Global Pharmacovigilance Safety Cooordinator. Main activities Document Preparation: Schedule and maintenance of the planning of all safety reports for the medicinal products and medical devices across the different geographies where Angelini is present Ensure proper coordination of safety reports preparation/submission/maintenance working in a matrix organization (indirect coordination of resources at HQ and Country level) Prepare and review pharmacovigilance and vigilance documents, including but not limited to Periodic Safety Update Reports (PSURs), Risk Management Plan (RMP), Addendum to the Clinical Overview (RMP), DSUR (Development Safety Update Report), Post Marketing Surveillance Plan (PSMP) and Report and other ad-hoc safety-related documents needed throughout the product's life cycle. Prepare the eCTD for the submission of the PSURs Ensure the safety reports submission compliance reporting to the Regulatory Authorities Prepare and coordinate safety reports responses to supplementary requests, deficiency letters, or similar Regulatory Authorities' requests received through the document assessment procedures. Collect and organize any safety and applicable data requested by business partners for the preparation of safety reports, as per the applicable PV agreement. Data Analysis: Analyze clinical and safety data to support the development of pharmacovigilance documents, including the evaluation of adverse events, relevant medical literature and safety signals. Collaboration: Collaborate with cross-functional teams, including local pharmacovigilance manager at country level, medical experts, regulatory affairs, clinical teams, and business partner where applicable, to gather information and ensure accurate and comprehensive document content. Quality Control: Conduct quality control checks to ensure accuracy, consistency, and completeness of documents, and make necessary revisions. Regulatory Compliance: Ensure all documents adhere to regulatory guidelines, including ICH (International Conference on Harmonisation) guidelines, Good Pharmacovigilance Practices (GVP), EMA guidelines and any other local and extra-European requirements, as applicable. Requirements: Bachelor's or advanced degree in life sciences, pharmacy, biology, medicine, or a related field At least 5 years of successful experience in the field of pharmacovigilance specifically within safety reports (PSUR, ACO, RMP, DSUR) management, gained in other pharmaceutical Companies In-depth Knowledge and understanding of regulatory and pharmacovigilance guidelines and requirements Scientific Acumen: Proficiency in medical and scientific terminology, as well as the ability to critically analyze clinical and safety data Fluent in English Communication Skills: Excellent written and verbal communication skills, as need to convey complex medical and scientific information clearly Collaboration: Ability to work effectively in cross-functional teams and collaborate with subject matter experts Time Management: Effective time management skills to meet tight deadlines in a regulated environment Innovative and critical thinking with performance-oriented drive We offer a permanent contract Location: Rome Angelini Pharma is an equal Opportunity Employer. We believe that diversity is a huge value that contributes to individual and company success. We are committed to create a diverse and inclusive environment. #J-18808-Ljbffr
-
Pharmacovigilance Manager – Italy
4 giorni fa
Lazio, Italia Resourcing Life Science A tempo pienoCompany Description Our client is currently seeking a Pharmacovigilance Manager in Italy.Job Overview Responsible for designing, implementing, and managing pharmacovigilance strategies and activities.Ensure the safety and compliance of pharmaceutical products.Collaborate with cross-functional teams, regulatory authorities, and external partners to maintain a...
-
Pharmacovigilance Manager – Italy
4 settimane fa
Lazio, Italia Resourcing Life Science A tempo pienoCompany DescriptionOur client is currently seeking a Pharmacovigilance Manager in Italy.Job OverviewResponsible for designing, implementing, and managing pharmacovigilance strategies and activities.Ensure the safety and compliance of pharmaceutical products.Collaborate with cross-functional teams, regulatory authorities, and external partners to maintain a...
-
Senior Drug Safety Specialist
4 settimane fa
Lazio, Italia Arithmostech A tempo pienoVia Squarcina, 13, Italy | Posted on 24/06/2024Industry: Pharma/Biotech/Clinical ResearchWork Experience: 1-3 yearsCity: Via Squarcina, 13Country: ItalyPostal Code: 00141Hybrid Job: YesAbout UsWe are experts in the Life Sciences industry & Technology.We are a long-standing partner for technology and expert service provider across Clinical, Regulatory,...
-
Safety Technician, Whs
5 mesi fa
Lazio, Italia Confidenziale A tempo pienoJob summary Amazon is looking for a Health and Safety Coordinator to add to the team: you maintain confidentiality in matters involving safety investigations, Flexibility on hours worked to cover shifts during Peak and ensure investigations are completed Support Fulfillment Center with safety administrative tools. Support Fulfillment Center providing H&S...
-
Area/Local Safety Officer Consultant
2 settimane fa
Lazio, Italia Clinchoice A tempo pienoArea/Local Safety Officer Consultantat ClinChoice (View all jobs)RomaniaAre you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds....ClinChoice is searching for an Area/Local Safety Officer Consultant for 12...
-
Senior Drug Safety Specialist
4 settimane fa
Lazio, Italia Arithmostech A tempo pienoVia Squarcina, 13, Italy | Posted on 24/06/2024Industry: Pharma/Biotech/Clinical ResearchWork Experience: 1-3 yearsCity: Via Squarcina, 13Country: ItalyPostal Code: 00141Hybrid Job: YesAbout Us We are experts in the Life Sciences industry & Technology.We are a long-standing partner for technology and expert service provider across Clinical, Regulatory,...
-
(Global Oil Gas) Senior Safety Engineer
1 mese fa
Lazio, Italia Matchatalent A tempo pienohis role required candidate to permanently relocate at Dhahran, Saudi Arabia. About the Company This company engages in the exploration, production, transportation, and sale of crude oil and natural gas. It operates through the following segments: Upstream, Downstream, and Corporate. The Upstream segment includes crude oil, natural gas and natural gas...
-
Global Media Coordinator
2 mesi fa
Lazio, Italia Zenithmedia A tempo pienoZenith is part ofPublicisGroupe , the world'sthirdlargestcommunications group.Whatcanwedo as Publicis Groupe?Known for its world-renowned creativity , best in class technology , digital and consulting expertise , Publicis Groupe is the only one in the industry able to best accompany its clients in their digital business transformation journey - anywhere in...
-
Global Account Coordinator
2 settimane fa
Lazio, Italia Zenith Usa A tempo pienoZenith is part of Publicis Groupe , the world's third largest communications group.What can we do as Publicis Groupe?Known for its world-renowned creativity , best in class technology , digital and consulting expertise , Publicis Groupe is the only one in the industry able to best accompany its clients in their digital business transformation journey -...
-
Lazio, Italia Matchatalent A tempo pienoThis role required candidate to permanently relocate at Dhahran, Saudi Arabia. About the Company This company engages in the exploration, production, transportation, and sale of crude oil and natural gas. It operates through the following segments: Upstream, Downstream, and Corporate. The Upstream segment includes crude oil, natural gas and natural gas...
-
Health And Safety Manager
1 mese fa
Lazio, Italia Iqm Selezione A tempo pienoOur client is an international organization active worldwide and searching for a Health and Safety Manager (Central and Southern Europe Area). The ideal candidate has the following requirements: Holds a Master degree in engineering or equivalent field; a BSc/BA in safety management or relevant field is preferred; More than 5 years of experience in...
-
Global Ehs Director
1 mese fa
Lazio, Italia Linesight A tempo pienoAs Global EHS Director at Linesight, you will work with highly experienced, culturally diverse, and passionate teams nurturing a strong social dynamic and a shared sense of achievement. You will gain vast industry experience that will open doors for you, extend your skillset and expand your perspective. We will empower, support, and enable you to take real...
-
Lazio, Italia Matchatalent A tempo pienohis role required candidate to permanently relocate at Dhahran, Saudi Arabia. About the Company This company engages in the exploration, production, transportation, and sale of crude oil and natural gas. It operates through the following segments: Upstream, Downstream, and Corporate. The Upstream segment includes crude oil, natural gas and natural gas...
-
Lazio, Italia Matchatalent A tempo pienoThis role requires the candidate to permanently relocate to Dhahran, Saudi Arabia. About the Company This company engages in the exploration, production, transportation, and sale of crude oil and natural gas. It operates through the following segments: Upstream, Downstream, and Corporate. The Upstream segment includes crude oil, natural gas, and natural gas...
-
Process Safety Engineer Senior
1 mese fa
Lazio, Italia Technip Energies Abu Dhabi A tempo pienoJOB DESCRIPTIONAbout Technip EnergiesAt Technip Energies, we believe in a better tomorrow and we believe we can make tomorrow better. With approximately 15,000 talented women and men, we are a global and leading engineering and technology company, with a clear vision to accelerate the energy transition. Designing and delivering added value energy solutions...
-
Health and Safety Advisor
3 mesi fa
Lazio, Italia Confidenziale A tempo pienoOur client is a big Confidenziale active worldwide and searching fora Health and Safety Advisor C&SEA. Confidenziale: - Contributes to the development of appropriate Health and Safety policies and practices, ensuring compliance witConfidenziale national legislation and witConfidenziale Commissions Corporate standards - Develops and encourages a good...
-
Global Technical Manager – Customized Food Programs
3 settimane fa
Lazio, Italia Sgs A tempo pienoJob DescriptionAs Global Technical Manager, you will be responsible for overseeing the technical development, deployment, and management of customized audit programs and food certification schemes within Business Assurance, including support, optimization, and acting as the lead technical contact and project manager for assigned Global Key Accounts.Under the...
-
Health and Safety Advisor
3 mesi fa
Lazio, Italia Confidenziale A tempo pienoOur client is a big company, active worldwide and searching for a Health and Safety Advisor C&SEA. The job: Contributes to the development of appropriate Health and Safety policies and practices, ensuring compliance with the national legislation and with the Commission’s Corporate standards. Develops and encourages a good health and safety culture and...
-
Lazio, Italia Matchatalent A tempo pienoThis role required candidate to permanently relocate at Ras Tanura, Saudi Arabia. About the Company This company engages in the exploration, production, transportation, and sale of crude oil and natural gas. It operates through the following segments: Upstream, Downstream, and Corporate. The Upstream segment includes crude oil, natural gas and natural gas...
-
Health And Safety Manager
2 mesi fa
Lazio, Italia Commonwealth War Graves Commission A tempo pieno```html Health And Safety Manager - Rome (Italy) or Larnaca (Cyprus) Location: CWGC Office in Rome (Italy) or in Larnaca (Cyprus) Contract Type: Permanent We are currently looking for a Health and Safety Manager based in Cyprus (Larnaca) or Rome (Italy) that would lead the implementation of a uniform Health and Safety (HS) management system across all CSEA...
