Sr. Scientist, Drug Safety

Overview

In conjunction with the Clinical Safety and Risk Management (CSRM) team, works to expand and apply clinical, pharmacological, and epidemiologic knowledge and information technology skills to managing the safety surveillance for assigned products.

Responsibilities

• Performs safety surveillance review of adverse experience reports as per SOP with the CSRM team in order to assist with the monitoring and description of the safety profile of assigned products and to identify and respond to safety issues.
  
  
• Prepares responses to safety inquiries from health care professionals, regulatory agencies, subsidiary staff and other internal customers in conjunction with the CSRM team assigned to the product.
  
  
• Develops working knowledge of pharmacovigilance and Risk Management Plans; begins to educate stakeholders outside or CSRM about risk management and role of CSRM.
  
  
• Core member of Risk Management Safety Team (RMST).
  
  Represents CSRM on cross functional teams and committees as appropriate.
  
  Assists the CSRM team with the development and evaluation of Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS) for assigned products.
  
  
• Assists in the preparation of manuscripts for submission to peer reviewed journals and gives poster and oral presentations at medical conferences on the safety profile of assigned products.
  
  Assists with the guidance of these documents through the internal clearance and external submission process.
  
  
• Participates in the development, implementation and evaluation of standards, processes, metrics and other department initiatives.
  
  

Qualifications/Requirements

• Physicians with 2 years of clinical practice
• Pharmaceutical industry or related experience is desirable
• Excellent writing and communication skills a must.
  
  Experience in data analysis or the interpretation of adverse experience information is a plus
• English level - advanced
• Good organization skills and time management
• Strategic thinking, driven, motivated
• Strong decision-making skills

Additional Information

Current Employees apply HERE

Current Contingent Workers apply HERE

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Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills: Accountability, Accountability, Adaptability, Adverse Event Report, Clinical Experience, Clinical Medicine, Communication, Data Analysis, Data Integrity, Decision Making, Drug Safety Surveillance, English Language, FDA Regulations, Good Clinical Practice (GCP), Medical Writing, Periodic Safety Update Reports, Pharmacovigilance, Risk Evaluation And Mitigation Strategy (REMS), Risk Management, Risk Management Programs, Safety Management, Safety Observations, Safety Reporting, Social Collaboration, Strategic Thinking

Preferred Skills:

Job Posting End Date: 10/11/2025

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