Drug Safety Consultant

ClinicalPro is seeking a Drug Safety Consultant for a leading Pharmaceutical company located in the USA.

This individual will be responsible for providing technical and programming assistance for drug safety and pharmacovigilance operations and overseeing small to medium-sized technical projects.

Must be eligible to work in the USA.

Responsibilities

• Managing user accounts, maintaining dictionaries, managing configurations, and managing the worldwide adverse event database.
• Program, verify, and produce recurring reports.
• Create and produce ad hoc reports to respond to inquiries from regulatory agencies (domestic and international), healthcare providers, and other client departments like law and medical affairs, etc.
• Work together on the creation, implementation, improvement, testing, and maintenance of applications.
• Identify technological problems and/or requirements.
• Analyse, create, program, and execute solutions.
• Provide technological knowledge to execute regulatory changes for preserving compliance and interpret regulatory changes as they affect technology.
• Make that all applicable policies and procedures are followed.
• Follow standard operating procedures, and make sure all compliance-related operations have the proper paperwork to support them.
• Master and keep up-to-date knowledge of US Federal Regulations and Guidelines directing the reporting of investigational and post-marketing adverse events.

Skills and Requirements

• Understanding of medical language and coding systems.
• Relevant expertise in clinical research and the pharmaceutical business, ideally in pharmacovigilance/drug safety.
• English proficiency required.
• Strong communication and computer literacy. capable of working well in a team atmosphere and detail-oriented.
• Bachelor’s degree or its equivalent

Apply

If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.

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