Sr. Scientist, Drug Safety

Bogotá - Colombia

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Description

Job description:

In conjunction with the/CSRM team works to expand and apply clinical pharmacological and epidemiologic knowledge and information technology skills to managing the safety surveillance for assigned products.
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.

Requirements:

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

Required Skills:

Accountability Accountability Adaptability Adverse Event Report Clinical Experience Clinical Medicine Communication Data Analysis Data Integrity Decision Making Drug Safety Surveillance Enterprise Risk Management (ERM) Good Clinical Practice (GCP) Job Descriptions Machine Learning Medical Writing Organizational Performance Management Pharmacotherapeutics Pharmacovigilance Product Safety Regulatory Affairs Management Regulatory Compliance Risk Evaluation And Mitigation Strategy (REMS) Risk Management Safety Management 3 more

Preferred Skills:

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/30/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Required Experience:

Senior IC

Job DescriptionJob description:In conjunction with the/CSRM team works to expand and apply clinical pharmacological and epidemiologic knowledge and information technology skills to managing the safety surveillance for assigned products.Performs safety surveillance review of adverse experience report...