Division: Drug Safety

Reports Into: Drug Safety Lead

We have an exciting opportunity available for an experienced Safety Data Management Specialist who will support our client’s Drug Safety Business Unit.

The successful candidate will play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating the framework necessary to ensure that evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our client’s mission is to empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

Responsibilities:

You will be relied on by the company to monitor the company’s drug, biologics and medical devices surveillance program. This will include intake, evaluation and processing of the adverse reports received. You will support the clinical trial as well as the post-marketing activities.

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Provide oversight, team mentoring on case handling aspects, data extraction and analyses and conduct follow-up activities.
• Act as subject matter expert and liaise with key partners regarding safety data collection and data reconciliation.
• Review, analyze, prepare, and complete safety-related reports within scope to determine the safety profile of the company’s products and to meet regulatory requirements.
• Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios.
• Manage, where applicable, safety resources in the local team.
• Provide specific pharmacovigilance or product knowledge and experience, as required by the business, and mentor colleagues accordingly.
• Develop and maintain advanced knowledge of all products within the company’s portfolio.
• Develop and maintain expertise of all assigned products, of applicable corporate policies.
• Design and oversee the tracking of applicable safety metrics.
• Manage project and process management meeting established deadlines.
• Search functions in the safety database and data mart.

Minimum Requirements:

• Bachelor’s Degree in Life Sciences
• Minimum of 12 months pharmacovigilance experience
• Demonstrated organizational/project management skills
• Solid knowledge of global regulations and guidelines for drug development
• Demonstrated analytical and statistical skills.
• Ability to make decisions independently and resolve issues appropriately
• Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
• Fluent in spoken and written English