Medical Director Global Patient Safety (Gps) Us - Remote Opportunity

Lundbeck

2-10 years

$240,000 - $280,000

Remote, USA

10 Oct. 22, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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

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 FDA and global regulatory pharmacovigilance guidelines. The incumbent will have a strong background in analyzing ‘Big Data’ and a solid understanding of methodologies and real-world data to support and enhance pharmacovigilance activities. Key responsibilities include medical assessment of adverse events, detection and evaluation of safety signals, and risk management activities throughout the lifecycle of assigned Lundbeck products.

ESSENTIAL FUNCTIONS

Medical Review and Assessment of Individual Case Safety Reports (ICSRs):
- Ensure medical accuracy, completeness, and quality of post-marketing and clinical trial ICSRs.
Aggregate Reports:
- Review the overall safety profile and risk/benefit ratio of Lundbeck products.
- Analyze safety data for inclusion in aggregate reports.
Signal Management:
- Generate safety data and develop analysis strategies for signal detection.
- Communicate changes in safety profiles internally and externally.
Risk Management:
- Oversee risk management activities and REMS programs for assigned products.
- Drive risk minimization strategies and support effectiveness measurements.
Other Deliverables:
- Chair safety committees for assigned products.
- Provide medical safety input for pharmacoepidemiology studies and label updates.

REQUIRED EDUCATION, EXPERIENCE, and SKILLS

Accredited MD/DO (MBBS, MBCHb, MBBCh).
5+ years of drug safety experience in a biotech or pharmaceutical company.
Strong understanding of aggregate data analysis and signal detection methodologies.
Excellent analytical and communication skills.
Knowledge of local and global pharmacovigilance regulations and risk management.

PREFERRED EDUCATION, EXPERIENCE, and SKILLS

2+ years of clinical practice experience in CNS Therapeutic Area (Psychiatry or Neurology).
10+ years of drug safety experience.
Advanced degree in Epidemiology and/or Master of Public Health (MPH).

TRAVEL

Willingness to travel up to 5% domestically; international travel may be required.

COMPENSATION

Salary Pay Range: $240,000 - $280,000, with eligibility for a 25% bonus target based on performance. Benefits include flexible paid time off (PTO), health benefits, and a company match 401k.

Why Lundbeck

Lundbeck offers a comprehensive benefits package to help employees live well and protect their health and family. For more information, please visit our U.S. career site.

Lundbeck is committed to providing reasonable accommodations to disabled veterans and individuals with disabilities during our application process. If you need an accommodation, please visit our U.S. career site.

Lundbeck is an equal opportunity workplace and an affirmative action employer, committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, or protected veteran status. Lundbeck participates in E-Verify.

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