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Medical Director, Late Stage Oncology-Product Safety Team Lead @AbbVie

[Hiring] Medical Director, Late Stage Oncology-Product Safety Team Lead @AbbVie

Mar 17, 2025 - AbbVie is hiring a remote Medical Director, Late Stage Oncology-Product Safety Team Lead. đź’¸ Salary: unspecified. đź“ŤLocation: USA.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

To lead Product Safety Teams (PST) and support one or more products as the PST Lead, ensuring that the safety profile of one or more products is adequately monitored and characterized throughout the product lifecycle (e.g., surveillance, signal detection and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

  • Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance.
  • Responsible for safety surveillance for pharmaceutical / biological / drug –device combination products.
  • Lead, oversee, and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, risk management plans, periodic safety reports (DSURs, PBRERs/PSURs, PADERs), etc.
  • Lead and oversee safety surveillance and pharmacovigilance activities for products in clinical development and marketed products, applying current regulatory guidance as appropriate.
  • Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams and regulatory authorities.
  • Effectively and independently write, review, and present technical documents.
  • Responsible for implementing risk management strategies for assigned products.
  • Proactively engaging, inspiring, coaching and mentoring team and colleagues.

Qualifications

  • MD / DO with 2+ years of residency with patient management experience.
  • Master Public Health is preferred in addition to MD / DO, not required.
  • 2-5 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.
  • Effectively analyze and guide analysis of clinical data and epidemiological information.
  • Effectively present recommendations / opinions in group environment both internally and externally.
  • Write, review and provide input on technical documents.
  • Work collaboratively and lead cross-functional teams.
  • Ability to lead cross-functional teams in a collaborative environment.
  • Fluency, both written and oral, in English.
  • Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask.

Benefits

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.

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Back to Remote jobs  >   All others
Medical Director, Late Stage Oncology-Product Safety Team Lead @AbbVie
All others
Salary đź’¸ unspecified
Remote Location
USA
Job Type full-time
Posted Mar 17, 2025
Apply for this position Unlock 52,193 Remote Jobs
️
đź“Ť Be aware of the location restriction for this remote position: USA
‼ Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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