Senior Pharmacovigilance Specialist - Patient Safety

Placements24; Monterrey; Hybrid; MXN 650,000 - 900,000; Full time

Job summary

Placements24 seeks a Senior Pharmacovigilance Specialist to lead adverse event monitoring and ensure regulatory compliance in Monterrey, Nuevo León. This role focuses on risk management and safety signal detection within a dynamic pharmaceutical environment.

You will collaborate with Medical Affairs, Regulatory Affairs, and Clinical Development, manage PSURs, data quality in safety databases, and provide PV training to stakeholders. A hybrid work setting is offered in Monterrey.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Biology, Chemistry, Medicine, or a related life science field.
• Minimum of 5 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations (FDA, EMA, COFEPRIS).
• Proven experience in signal detection, risk assessment, and reporting.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong understanding of medical terminology and drug classifications.

Responsibilities

• Monitor, collect, and evaluate adverse event reports for assigned products.
• Ensure compliance with national and international pharmacovigilance regulations and guidelines.
• Prepare and submit regulatory reports, including PSURs and other safety-related documents.
• Collaborate with cross-functional teams (Medical Affairs, Regulatory Affairs, Clinical Development) to ensure consistent safety messaging.
• Conduct signal detection activities to identify potential new safety concerns.
• Contribute to the development and implementation of pharmacovigilance processes and SOPs.
• Provide training and guidance to internal and external stakeholders on pharmacovigilance matters.
• Manage safety database entries and ensure data accuracy and completeness.
• Participate in internal and external audits and inspections related to pharmacovigilance.
• Stay updated on the latest scientific literature and regulatory changes impacting pharmacovigilance.

Skills

Analytical thinking

Problem-solving

Critical thinking

Communication skills

Spanish language proficiency

English language (desirable)

Education

Bachelor's or Master's degree in Pharmacy, Biology, Chemistry, Medicine, or related life science field

Tools

Argus

ARISg

Safety reporting tools

Job description

Placements24 seeks a Senior Pharmacovigilance Specialist to lead adverse event monitoring and ensure regulatory compliance in Monterrey, Nuevo León. This role focuses on risk management and safety signal detection within a dynamic pharmaceutical environment.

You will collaborate with Medical Affairs, Regulatory Affairs, and Clinical Development, manage PSURs, data quality in safety databases, and provide PV training to stakeholders. A hybrid work setting is offered in Monterrey.