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Medical Director, Global Pharmacovigilance-US

 
Requisition ID:  1078
Location: 

Deerfield, Illinois, US

Date: 
 

At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.

 

 

SUMMARY:  

This position is responsible for monitoring the safety profile of assigned Lundbeck products according to the FDA and global regulatory Pharmacovigilance guidelines. Other key responsibilities include medical assessment of adverse events reported from post-marketing experience and clinical trials; the detection and evaluation of safety signals and risk management activities. Additional responsibilities relate to a global understanding of pharmacovigilance and risk management regulations and guidelines. Individual and team contribution to the development of departmental and intradepartmental processes and procedures is expected.

 

ESSENTIAL FUNCTIONS: 

 

Individual Case Safety Reports (ICSRs)
•    Interfaces with Clinical team for clinical studies. Participates in clinical project meetings and in investigator meetings. Monitors safety of ongoing clinical studies by reviewing and assessing AE/SAE, lab data, providing input for further actions. Leads the preparation and review of safety aspects of clinical study protocols, CSRs, IBs, ICFs, investigator communications and IND/NDA safety updates.
•    Ensures accuracy, completeness and quality of post marketing and clinical trial ICSRs
•    Reviews clinical and post-marketing AE/SAE/PC reports and analyzes aggregate safety data; provides medical assessment; and instructs staff for appropriate query and follow-up activities. 

 

Aggregate Reports
•    Performs medical assessment for expedited reporting of ICSRs and review of IND & EU annual reports, FDA Periodic Reports and Periodic Safety Update Reports (PSURs/PBRERs) and DSURs. 
•    Contributes to and provides medical safety leadership for the detailed review of the overall safety profile and risk/benefit ratio of Lundbeck products and drug candidates as directed (at intervals specified by ICH and regulatory authorities, but not less than once per year).

 

Risk Management, Pharmacoepidemiology and Literature Surveillance
•    Leads product safety evaluation and Pharmacovigilance Plans in NDA/BLAs 
•    Contributes medical safety input to produce Risk Management Plans, RiskMAPS and REMS.  Accountable for implementation of a measurement of effectiveness of REMS and risk management plans/RiskMAPS.
•    Provides medical safety input into the design and conduct of pharmacoepidemiology studies. 
•    Ongoing review of worldwide scientific literature related to Lundbeck products as required by global regulations and internal processes and communicating safety information in the aggregate reports

 

Signal Management
•    Leads the review of reports from signaling and data mining activities utilizing internal and external sources of data.
•    Contributes to developing methodologies for establishing thresholds for assigned product safety signal activities.
•    Leads periodic safety data review to identify safety signals and performs risk/benefit assessments for responsible products. 
•    Prepares and presents information (i.e. graphs, tables and reports) related to safety profile observations to project teams and senior management


Labeling, CCDS Management and Regulatory Authorities Request Management
•    Participating in discussions on company labeling management process, providing input into updates to the company core safety information and safety sections of product labels. 
•    Participates in the development of CCDS and local labels. 
•    Perform responsible and timely handling of safety issues/safety requests from authorities and other internal/external parties

 

Organizational Improvement  
•    Leads in the development and update of department systems, policies, procedures and guidelines.
•    Responsible for the continuous process improvement in collaboration with the other functional areas and the PV Medical Safety team.
•    Provides direction and guidance to PV staff for activities in case management, compliance and risk management systems.
•    Participation in relevant cross functional/organizational projects
•    Cross functional collaboration with other NA R&D functions as well as the global PV organization to execute on shared goals across Lundbeck

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS: 
•    Accredited MD/DO (MBBS, MBCHb, MBBCh) 
•    1+ years drug safety experience in a biotech or pharmaceutical company.
•    Working knowledge of regulatory reporting guidelines and requirements with regard to safety in the pharmaceutical industry.  
•    Excellent analytical, organizational, written and verbal skills.  
•    Ability to work well with modest supervision in a fast-paced environment. 
•    Excellent interpersonal skills with the ability to deal effectively and tactfully with providers of adverse event information and to assist others in interpretation of the data. 
•    Excellent computer skills with experience using a Safety database.

 

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
•    2+ years of clinical practice experience
•    3+ years drug safety experience in a biotech or pharmaceutical company.
•    Advanced degree in Epidemiology and/or Master in Public Health (MPH)

 

TRAVEL
•    Willingness to travel up to 5% domestically. International travel may be required.

 

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. 

An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.
Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.