Senior Specialist, Drug Safety

Bogotá - Colombia

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Job Description

The Senior Specialist collaborates with cross-functional colleagues to support operational regulatory pharmacovigilance company policies processes standards and software system configuration that impact individual case safety reports aggregate reports and downstream medical review and safety signaling activities. Maintains Pharmacovigilance global standards for relevant activities to ensure compliance and quality aligned with (software development lifecycle) and global requirements.

Core Responsibilities

Develop and maintain the necessary processes and training to ensure high quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations.

Participate in interdepartmental and cross-functional meetings to support operational and regulatory PV requirements and deliverable

Maintain knowledge of PV regulations related to drugs vaccines biologics and devices.

Collaborate with internal and external stakeholders with processes that ensure compliance with local and global PV regulations.

Process incoming requests from internal and external sources related to PV requirements and assist in development of an appropriate course of action and/or response.

Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits as applicable.

Support integration of acquisitions collaborations and partnerships

Collaborates with MRK IT to implement and manage system improvements and updates to the safety database and systems supporting PV activities

Participate and/or lead in the development of processes with internal and external stakeholders to ensure quality and compliance of individual case and aggregate safety reports

Perform quality review of individual case and aggregate safety reports to ensure adherence to global case processing standards and regulatory requirements

Perform investigations of late individual case and aggregate safety reports including root cause analysis and development of corrective and preventive action plans

Compile metrics for individual case and aggregate safety reports

Track Advent Events metrics

Contribute to aggregate safety reports content such as generating and/or reviewing output and patient exposure data

Collaborate with Business Process Owners to improve departmental efficiencies and continuous improvement

Monitor group mailboxes utilized for the centralization of process/subject specific inquiries

Serve as subject matter expert for individual case and aggregate safety report types.

Education Requirement:

Required: Bachelors degree or masters degree in a life science/ health care/pharmaceutical related field or MD/DO/International equivalent

A minimum 2 years of work experience in pharmaceutical health care clinical trials clinical drug development and/or drug safety experience required.

Advanced English - Business level

Required Qualifications & Skills:

Knowledge and understanding of Pharmacovigilance processes and regulations

Knowledge of safety reporting data collection requirements

Problem solving and implementation of solutions with oversight

Experience working in a cross-functional team setting

Strong interpersonal skills and Strong communication skills

Project management ability to plan and coordinate work activities with others time management skills. Able to drive projects to completion

Strong attention to detail and production of quality work

Proactively seeks out advice and information from others when addressing business issues

Computer database skills familiar with Microsoft Office tools

Required Skills:

Accountability Accountability Adaptability Adverse Event Report Auditing Biopharmaceuticals Business Processes Communication Compliance Monitoring Data Analysis Decision Making Drug Development Drug Safety Surveillance Immunotherapy Medical Review Personal Development Pharmaceutical Regulatory Compliance Pharmacovigilance Project Management Regulatory Compliance Regulatory Reporting Regulatory Requirements Risk Management Safety Procedures Software Development 5 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:

02/6/2026

*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 DescriptionThe Senior Specialist collaborates with cross-functional colleagues to support operational regulatory pharmacovigilance company policies processes standards and software system configuration that impact individual case safety reports aggregate reports and downstream medical review and...