Senior Drug Safety Specialist - Hybrid PV

MSD; Guaduas; Hybrid; COP 120,000,000 - 180,000,000; Full time

Job summary

Merck & Co., Inc. in Colombia seeks a Senior Specialist, Drug Safety to develop and maintain PV processes ensuring high-quality reporting in compliance with PV regulations.

You will collaborate with internal and external stakeholders to maintain global PV compliance across drugs, vaccines, biologics and devices. The role involves leading process development, supporting the SDLC for safety systems, and contributing to manuals, SOPs, and training.

Qualifications

• Bachelor’s or Master’s in life sciences or related field.
• At least two years in pharmacovigilance or related areas such as Clinical Risk Management, Clinical or Regulatory.
• Strong knowledge of pharmacovigilance principles with attention to detail.
• Demonstrates leadership and communication skills; able to manage projects to completion.

Responsibilities

• Lead development of PV processes with stakeholders to ensure quality and regulatory compliance.
• Support end-to-end ICSR lifecycle data handling and reporting.
• Maintain PV system configurations and training materials.
• Ensure compliance with global PV regulations and inspections.
• Assist in due diligence and qualification activities for partner deals.

Skills

Pharmacovigilance

Leadership

Communication

Project management

Attention to detail

Education

Bachelor’s or Master’s degree in life sciences/health care/pharmaceutical field

Job description

Merck & Co., Inc. in Colombia seeks a Senior Specialist, Drug Safety to develop and maintain PV processes ensuring high-quality reporting in compliance with PV regulations.

You will collaborate with internal and external stakeholders to maintain global PV compliance across drugs, vaccines, biologics and devices. The role involves leading process development, supporting the SDLC for safety systems, and contributing to manuals, SOPs, and training.