Manager, Safety Scientist
New
B
BeOnePharmacovigilance
Brazil RemoteFull-TimeManager
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Languages
- Fluent English is Required
- Experience
- 2+ years as a Safety (Pharmacovigilance) Scientist.
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Hold a PharmD, RN, or PhD/MS in a medical field or biological science.
- Have 2+ years of experience as a Safety (Pharmacovigilance) Scientist.
- Have pharmaceutical product development experience.
- Have experience with global regulatory requirements for pharmacovigilance.
- Know how to retrieve safety information using a safety database such as Argus.
- Have intermediate knowledge of MedDRA and signal management systems.
- Have advanced application capability with Excel, PowerPoint, Word, and an electronic document management system such as Veeva.
- Be familiar with data mining and analysis tools such as Spotfire and Power BI.
- Be fluent in English.
Responsibilities
- Identify, analyze, and evaluate safety data from applicable sources for signal detection.
- Conduct signal detection and assessment, document findings, and support safety evaluations.
- Collaborate with Product Safety Leads and cross-functional colleagues on safety analysis and risk assessment.
- Prepare and present safety data for safety governance and monitoring committees.
- Monitor safety data for allocated clinical trials and provide safety expertise for study documents.
- Contribute to safety sections of regulatory submissions and aggregate safety reports.
- Analyze safety data and prepare responses to health authority inquiries and periodic reporting requirements.
- Support safety communications, investigator training, and safety team meetings.
View Full Description & ApplyYou'll be redirected to the employer's site
