Medical Director Global Patient Safety Specialist

4 weeks ago


Deerfield Beach, Florida, United States Lundbeck Full time
Job Summary:

This position is responsible for monitoring the safety profile of assigned Lundbeck products according to the FDA and global regulatory Pharmacovigilance guidelines. The incumbent will have a strong background and experience with analyses of 'Big Data', with a good understanding of the methodologies and leveraging real-world data to support and enhance PV activities. This individual has a solid understanding of global PV regulations and maintains oversight of safety related post approval commitments, risk minimization activities and any mandated REMS programs throughout the life cycle of assigned Lundbeck products.

Key Responsibilities:

Ensures medical accuracy, completeness and quality of post marketing and clinical trial ICSRs, and instructs staff for appropriate follow-up
Responsible for the detailed review of the overall safety profile and risk/benefit ratio of Lundbeck products and drug candidates as directed
Accountable for the scientific content and analysis of safety data/information for inclusion into aggregate reports
Responsible for safety data generation, developing analysis strategies, and drawing scientifically sound conclusions based on review of various data sources for signal detection
Presents findings from signal detection activities to other Safety Team members, as well as safety governance bodies
Maintains oversight of risk management activities and REMS programs for assigned products
Drives risk minimisation strategies and takes accountability for the medical-scientific content in the Risk Management Plans, including risk minimization measures, risk minimization action plans (RiskMAPS) and REMS programs, as relevant

Requirements:

Accredited MD/DO (MBBS, MBCHb, MBBCh)
5+ years drug safety experience in a biotech or pharmaceutical company
Ability to drive drug safety evidence generation and risk mitigation strategies in a highly complex internal and external environment
Solid understanding of aggregate data analysis and, scientific methodologies for signal detection
Excellent analytical skills and ability to synthetize large amounts of data and to make sound medical interpretation of data
A good understanding and experience with applying methodologies and leveraging real-world data to support and enhance PV activities
Excellent working knowledge of local and global regulations/guidelines in pharmacovigilance and risk management, REMS programs
Ability to work well with modest supervision in a fast-paced environment
Strong interpersonal, organisational and communication (written and verbal) skills
Excellent computer skills with experience using a safety database

About Lundbeck:

Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives.

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