Job Description
Responsibilities Review serious adverse experience (SAE) information received from Investigator sites and adverse experiences (AEs) from post marketing sources for completeness and regulatory compliance
Prepare safety data reports for submissions to clients
Prepare expedited Safety Reports for submission to Regulatory Authorities
Assist in representation of Global Safety and Pharmacovigilance group at project team and client meetings
Communicate with Clinical Operations and clients to ensure compliance with safety and Pharmacovigilance SOPs
Assist in compilation of regulatory submissions, i.e., Annual Reports Periodic Safety Update Reports
Assist the safety lead for projects; to include set up , project management, client liaison
Perform literature searches
Assist with SAE reconciliations
Desired Profile
RequirementsBachelors Degree in a life science or nursing; or RN diploma; in Lieu of degree a total of four years relevant experience may be considered.
One year relevant experience in Safety/Pharmacovigilance required which may include up to 2 years of data management, CRA, clinical practice (RN, RPN). Health authority of study coordinator experience
Good Verbal and written communication skills
Good Knowledge of ICH guidelines and regulations relating to Safety Reporting
Education:UG -Diploma - Any Specialization, B.Sc - Any Specialization, Nursing
PG - Any Postgraduate
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