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Associate Medical Director, Pharmacovigilance Risk Management - Remote

Posted 2 weeks ago
All others
Full Time
USA
$180,400 - $225,500/year

Overview

The Associate Medical Director will provide hands-on support for pharmacovigilance risk management for investigational and commercial products, ensuring medical safety throughout the product lifecycle.

In Short

  • Monitor and assess risk/benefit for assigned products.
  • Conduct safety surveillance and review clinical trial safety data.
  • Generate safety queries and evaluate safety data.
  • Contribute to Risk Management Plans and safety evaluations.
  • Prepare and present safety information to project teams.
  • Ensure timely review of Individual Case Safety Reports (ICSRs).
  • Participate in cross-functional drug development teams.
  • Handle regulatory safety inquiries and evaluations.
  • Manage external vendor's Medical PV operations.
  • Support ad-hoc projects requiring safety input.

Requirements

  • Medical Degree (MD) with 3-5 years of drug safety experience.
  • Experience in Oncology and Neurology preferred.
  • Strong understanding of pharmacovigilance regulations.
  • Expertise in medical review of safety reports.
  • Knowledge of drug development and clinical research.
  • Excellent communication skills in English.
  • Ability to work in a fast-paced environment.
  • Strong interpersonal skills and teamwork abilities.
  • High level of initiative and independence.
  • Ability to manage multiple demands effectively.

Benefits

  • Merit-based salary increases.
  • Participation in short incentive plans.
  • Eligibility for 401(k) plan.
  • Comprehensive medical, dental, and vision insurance.
  • Flexible paid time off and 11 paid holidays.
  • Paid sick time upon hire and annually.
  • Additional time off during the last week of December.
  • Support for continuing education and training.
  • Opportunity to work in a dynamic and innovative environment.
  • Commitment to a culture of “Safety First”.

S.P.A

Sumitomo Pharma America

Sumitomo Pharma America, Inc. is a subsidiary of Sumitomo Pharma Co., Ltd., a global pharmaceutical company headquartered in Japan. The company operates in the U.S., Canada, and Europe, focusing on addressing patient needs across various therapeutic areas, including oncology, urology, women's health, rare diseases, psychiatry, neurology, and cell and gene therapies. With a diverse pipeline of products and advanced technology capabilities, Sumitomo Pharma America is dedicated to accelerating the discovery, research, and development of innovative therapies to improve patient outcomes. The company is committed to ethical practices and fostering a culturally diverse workforce, aiming to create value through innovative research and development for the betterment of healthcare worldwide.

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