GSK

SERM Associate Medical Director

GSK

full-time

Posted on:

Location Type: Office

Location: Wavre • 🇧🇪 Belgium

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Job Level

Lead

About the role

  • Provides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.
  • Ensures scientifically sound review and interpretation of data and management of safety issues.
  • Makes recommendations for the further characterization, management, and communication of safety risks.
  • Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
  • If appointed as a manager is responsible for leadership of a team of individual contributors.

Requirements

  • Relevant experience in pharmacovigilance or drug development
  • Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
  • Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
  • Experience working in large matrix organizations
Benefits
  • Health Sciences/Health Care professional degree required as a medical doctor/physician
  • Advanced degree preferred

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
pharmacovigilancesafety evaluationrisk managementdata interpretationbenefit-risk managementdrug developmentpost-marketing activitiesclinical developmentinternational pharmacovigilance requirementsdrug approval processes
Soft skills
leadershipteam managementcommunication