Core Data Sheets Manager

Job description

Job Description

Major activities:
• Ensures patient safety through timely and adequate updates of the core safety information of marketed products
• Tracks signals in the signal management tracking system, and evaluates line listings and safety information in scientific literature, including reference product information and regulatory authority communication.
• Works closely with affiliates to harmonize labelling, periodically collect compliance information and prepare management reports
• Prepares, and drives timeliness, volume and high quality of CDS documents
• Assists in managing 3rd party providers for the production of CDS and other documents
• Prepares data packages required by 3rd party providers. Reviews and qualifies CDSs deliveries from providers
Educational background and experience:
• Health Care Professional with regulatory background, i.e., Pharmacist, PharmD, MD and equivalent
• Experience in safety document writing, labelling and DRA activities for >5 years.
• Established knowledge of, and experience in the EU drug regulatory environment and drug approval procedures
• Familiarity with EU signal sources / regulatory bodies
• Fluency in English, including medical / pharmaceutical terminology. Knowledge of other languages desirable and necessary
• At least 1 year of experience in drug safety/development or closely related areas of responsibility
• Experience of safety document writing
• Good negotiation, proactive and performance oriented, project management and communication skills
• Fluency in EU and US regulation

Desired profile

Minimum requirements

Major activities:
• Ensures patient safety through timely and adequate updates of the core safety information of marketed products
• Tracks signals in the signal management tracking system, and evaluates line listings and safety information in scientific literature, including reference product information and regulatory authority communication.
• Works closely with affiliates to harmonize labelling, periodically collect compliance information and prepare management reports
• Prepares, and drives timeliness, volume and high quality of CDS documents
• Assists in managing 3rd party providers for the production of CDS and other documents
• Prepares data packages required by 3rd party providers. Reviews and qualifies CDSs deliveries from providers
Educational background and experience:
• Health Care Professional with regulatory background, i.e., Pharmacist, PharmD, MD and equivalent
• Experience in safety document writing, labelling and DRA activities for >5 years.
• Established knowledge of, and experience in the EU drug regulatory environment and drug approval procedures
• Familiarity with EU signal sources / regulatory bodies
• Fluency in English, including medical / pharmaceutical terminology. Knowledge of other languages desirable and necessary
• At least 1 year of experience in drug safety/development or closely related areas of responsibility
• Experience of safety document writing
• Good negotiation, proactive and performance oriented, project management and communication skills
• Fluency in EU and US regulation