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Pharmacovigilance Scientist
Eingestellt von RM IT Professional Resources AG
Gesuchte Skills: Support, Client
Projektbeschreibung
Pharmacovigilance Scientist wanted for our Zurich based client in the pharmaceutical sector.
YOUR EXPERIENCE/SKILLS:
- Life science degree (BSc, MSc) and 5+ years' experience in clinical trials and postmarketing pharmacovigilance
- 3+ years' of pharmaceutical or biotechnology industry as a Pharmacovigilance specialist
- Solid investigational event and aggregate assessment/review/documentation skills and expertise in Aggregate Report preparation and review
- Working knowledge of US/EU/APAC regulations and ICH guidelines as well as experience in communicating with the FDA, EMA, and other global health authorities
- Profound working knowledge of MedDRA coding and understanding of pharmacovigilance-related information systems
- Languages: fluent English both written and spoken
YOUR TASKS:
- Providing PV support for developmental programs, including both early and late stage development
- Backing Vaccines Safety lead for assigned products, eg by performing compilation, analysis and review of safety data and safety signal management for designated compounds
- Preparing PV section for clinical study protocols, SAPs, clinical study reports, and other documents developed for submission to regulatory authorities
- Developing Aggregate Reports: Co-authors Aggregate Reports (PSURs, DSURs) and contributes to the preparation of Ad Hoc Safety Reports such as Health Hazard Evaluations
- Reviewing safety data and participating in dose escalation/continuation of vaccination decisions as well as contributing to Safety Monitoring Plan/Risk Management Plan
- Performing data analysis and drafts regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
START: ASAP
DURATION: 12MM+
LOCATION: Zurich, Switzerland
REF.NR.: BH12834
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
YOUR EXPERIENCE/SKILLS:
- Life science degree (BSc, MSc) and 5+ years' experience in clinical trials and postmarketing pharmacovigilance
- 3+ years' of pharmaceutical or biotechnology industry as a Pharmacovigilance specialist
- Solid investigational event and aggregate assessment/review/documentation skills and expertise in Aggregate Report preparation and review
- Working knowledge of US/EU/APAC regulations and ICH guidelines as well as experience in communicating with the FDA, EMA, and other global health authorities
- Profound working knowledge of MedDRA coding and understanding of pharmacovigilance-related information systems
- Languages: fluent English both written and spoken
YOUR TASKS:
- Providing PV support for developmental programs, including both early and late stage development
- Backing Vaccines Safety lead for assigned products, eg by performing compilation, analysis and review of safety data and safety signal management for designated compounds
- Preparing PV section for clinical study protocols, SAPs, clinical study reports, and other documents developed for submission to regulatory authorities
- Developing Aggregate Reports: Co-authors Aggregate Reports (PSURs, DSURs) and contributes to the preparation of Ad Hoc Safety Reports such as Health Hazard Evaluations
- Reviewing safety data and participating in dose escalation/continuation of vaccination decisions as well as contributing to Safety Monitoring Plan/Risk Management Plan
- Performing data analysis and drafts regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
START: ASAP
DURATION: 12MM+
LOCATION: Zurich, Switzerland
REF.NR.: BH12834
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Sonstiges