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Senior Scientist – Drug Safety

MSD LATAM · Bogota

Senior 🇬🇧 English
Data Analysis Data Integrity Drug Safety Surveillance Good Clinical Practice (GCP) Medical Writing Pharmacovigilance Regulatory Compliance Risk Management Safety Reporting

Descripcion del puesto

About the role

The Senior Scientist, Drug Safety will join Merck's Clinical Safety and Risk Management (CSRM) team to lead safety surveillance activities for assigned pharmaceutical products. This role combines clinical, pharmacological, and epidemiologic expertise with data analysis to protect patient health.

Key responsibilities

  • Conduct safety surveillance reviews of adverse experience reports in accordance with SOPs.
  • Prepare and deliver responses to safety inquiries from healthcare professionals, regulators, and internal stakeholders.
  • Develop and maintain knowledge of pharmacovigilance, Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS).
  • Represent CSRM on cross‑functional teams and serve as a core member of the Risk Management Safety Team.
  • Assist in drafting manuscripts, posters, and oral presentations for medical conferences.
  • Support the creation, evaluation, and internal/external clearance of RMPs and REMS.
  • Participate in the development and improvement of departmental standards, processes, and metrics.

Required profile

  • Physician with at least 2 years of clinical practice.
  • Pharmaceutical industry experience is desirable.
  • Advanced English communication and writing skills.
  • Strong organizational, strategic thinking, and decision‑making abilities.
  • Experience in data analysis or interpretation of adverse event information is a plus.

Required skills

  • Adverse Event Reporting
  • Data Analysis
  • Data Integrity
  • Drug Safety Surveillance
  • Good Clinical Practice (GCP)
  • Medical Writing
  • Pharmacovigilance
  • Regulatory Compliance
  • Risk Management
  • Safety Reporting

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