- Ensures medical accuracy, completeness and quality of post marketing and clinical trial ICSRs, and instructs staff for appropriate follow-up
- Contributes to the detailed review of the overall safety profile and risk/benefit ratio of Lundbeck products and drug candidates as directed
- Ensures timely preparation and analysis of safety data/information for inclusion into aggregate report
- Conducts the review of safety data from various data sources
- Presents findings from signal detection activities to other Safety Team members, as well as safety governance bodies
- Contributes with medical-scientific input to Risk Management Plans, RiskMAPS and REMS, as relevant
- Supports the implementation of a measurement of effectiveness of additional risk minimization measures and REMS
- Provides medical safety input into the design and conduct of pharmacoepidemiology studies
- Provides medical safety input in relation to CCDS and label updates
- Prepares responses to safety-related requests from health authorities and other external parties
- Participation in relevant cross functional/GPS organizational projects as assigned
- 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 regarding safety in the pharmaceutical industry
- Good analytical skills and ability to make sound medical interpretation of data
- Ability to work well with modest supervision in a fast-paced environment
- Strong interpersonal, organizational and communication (written and verbal) skills
- Excellent computer skills with experience using a safety database
- 2 years of clinical practice experience in CNS Therapeutic Area (Psychiatry or Neurology)
- 3 years drug safety experience in a biotech or pharmaceutical company.
- Advanced degree in Epidemiology and/or Master of Public Health (MPH)
- Willingness/Ability to travel up to 5% domestically. International travel may be required.
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Medical Director GPS US - Deerfield, United States - Lundbeck
Description
Medical Director GPS US - Remote OpportunityRequisition ID: 5173
Location:
Deerfield, Illinois, US
Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best.
Remote opportunity - open to candidates anywhere in the greater United States
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 include contribution to the development of Global Medical Safety and cross-functional processes and procedures.ESSENTIAL FUNCTIONS:
Medical Review and Assessment of Individual Case Safety Reports (ICSRs) :
Aggregate Reports (e.g. PSUR/PBRER, DSUR, PADER)
Signal Management, including literature surveillance
Risk Management
Other deliverables
Other Organizational Project Assignment
REQUIRED EDUCATION, EXPERIENCE, and SKILLS:
PREFERRED EDUCATION, EXPERIENCE, and SKILLS:
TRAVEL:
Salary Pay Range:
$240,000 - $285,000andeligibilityfor a25%bonustargetbased on company and individual performance,and eligibilitytoparticipate in the company's long-term incentive plan.
Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k.
Additional benefits information can be found onour site . Applications accepted on an ongoing basis. \#LI-LM1, #LI-RemoteWhy Lundbeck
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life.
_Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process.
If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit theU.S.
career site ) .__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 inE-Verify \_Participation\_Poster\_Eng\) ._About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges.
Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate.
We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.
About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges.
Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate.
We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.
