Opening for the post of Safety Associate I @ inVentiv Health Clinical
Job Description
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
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Bio-Technical Research Associate/Scientist
Role: Bio-Technical Research Associate/Scientist
Keyskills: Clinical, CRO, InVentiv, Drug Safety, Pharmacovigilance, Case Processing, Argus, ArisG, Quality Reviews, Regulatory
Desired Profile
Bachelors 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 -Any Graduate - Any Specialization, Graduation Not Required
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Company Profile
inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.
Click here to apply
Job Description
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
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Bio-Technical Research Associate/Scientist
Role: Bio-Technical Research Associate/Scientist
Keyskills: Clinical, CRO, InVentiv, Drug Safety, Pharmacovigilance, Case Processing, Argus, ArisG, Quality Reviews, Regulatory
Desired Profile
Bachelors 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 -Any Graduate - Any Specialization, Graduation Not Required
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Company Profile
inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.
Click here to apply
Clinical Research Industry inviting Pharma & Life Science Candidates.
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