inVentiv Health 0000101299-Global Med Safety Physician in United States
The Safety Physician for Labelling Support supports the product-responsible post-marketing safety physician in all activities related to core safety labelling documents for Consumer products. He/she will provide medical oversight on the preparation of supporting documents for safety-related information and on responses to related health authority inquiries.
The Safety Physician will advise on the strategy and analysis for safety-related labelling information and review the results. He/she will determine the medical importance of safety-related information in core labelling documents.
The Safety Physician for Labelling Support will be responsible for advising on the strategy and analysis for safety-related labelling information and will review the results. He/she will ensure that the safety supporting documents are of high medical and scientific quality.
• Collaborate with the medical safety scientist to develop the report strategy and advise on the analysis
• Review the draft supporting documents for safety-related labelling information
• Attend label working group meetings and contribute to the content of the core labelling information
• Adhere to report timelines and escalate issues to management as appropriate
• Provide strategy and/or develop responses to health authority inquiries related to labelling information
• Doctor of Medicine (MD), or equivalent with clinical experience.
• Minimum of 3 years' experience in clinical/pharmaceutical medicine with 2 years of experience in pharmacovigilance and/or drug/device safety
• Experience in preparing post-marketing safety or clinical safety assessments, risk/benefit evaluations and regulatory reports; experience in preparing RMPs, PSURs
• Strong English verbal and written communication skills
• Awareness of applicable regulations and guidance related to post-marketing aggregate safety requirements
• Experience using Microsoft word templates.
For further details or to apply for this job, please contact:email@example.com
inVentiv Health, Inc. is an Equal Opportunity Employer, M/F/Disabled/Vets that values the strength that diversity brings to the workplace.