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Medical Safety Manager
A company is looking for a Manager, Medical Safety (Remote). Key Responsibilities Prepare aggregate safety reports (PBRERs, DSURs, PADERs) and author relevant safety sections Support signal management processes and assist in producing evaluation documents with clear conclusions Collaborate with project teams on risk management plans and support regulatory submissions for new products Required Qualifications, Training, and Education At least 2 years of experience in pharmacovigilance (PV) functions, particularly in safety reporting and risk management Working knowledge of PV regulations regarding aggregate safety reports and signal management Requires a degree in a life science field (e.g., nursing, pharmacy) or a relevant scientific/technical discipline Familiarity with MedDRA and safety databases Proficiency with Windows applications and ability to learn new programs/databases
A company is looking for a Manager, Medical Safety (Remote).
Key Responsibilities
Prepare aggregate safety reports (PBRERs, DSURs, PADERs) and author relevant safety sections
Support signal management processes and assist in producing evaluation documents with clear conclusions
Collaborate with project teams on risk management plans and support regulatory submissions for new products
Required Qualifications, Training, and Education
At least 2 years of experience in pharmacovigilance (PV) functions, particularly in safety reporting and risk management
Working knowledge of PV regulations regarding aggregate safety reports and signal management
Requires a degree in a life science field (e.g., nursing, pharmacy) or a relevant scientific/technical discipline
Familiarity with MedDRA and safety databases
Proficiency with Windows applications and ability to learn new programs/databases