Especialista en Farmacovigilancia en Cancún

Placements24; Cancún; Hybrid; MXN 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Retirement plan

Paid time off

Job summary

Placements24 is seeking a Pharmacovigilance Specialist for a globally recognized pharmaceutical company with a Cancún connection. You will monitor adverse events, assess causality, and ensure regulatory compliance while working remotely with close collaboration to our Quintana Roo hub.

The role requires a Master’s or Ph.D. in a life sciences field, 4+ years in pharmacovigilance, and experience with Argus/ArisG.

Qualifications

• Master's degree or Ph.D. in Pharmacy, Medicine, Life Sciences, or related field.
• Minimum of 4 years of direct pharmacovigilance or drug safety experience.
• Thorough understanding of CIOMS, ICH, FDA, EMA regulations.
• Experience with pharmacovigilance databases and safety reporting systems like Argus and ArisG.
• Strong analytical, critical thinking, and problem-solving skills.
• Excellent written and verbal communication; remote work capability.

Responsibilities

• Collect, process, and evaluate adverse event reports from healthcare professionals, patients, and trials.
• Assess AE data to determine causality and safety signals.
• Prepare and submit regulatory drug safety reports to health authorities.
• Develop and implement pharmacovigilance strategies per regulatory guidelines.
• Monitor emerging safety trends and advise on risk management.
• Collaborate with regulatory, medical, and clinical teams and external partners.
• Maintain PV databases and records with accuracy.
• Contribute to labeling and regulatory submissions.
• Maintain safety compliance in company databases and systems.
• Stay updated on global regulatory requirements and PV best practices.

Skills

Analytical skills

Critical thinking

Problem solving

Communication skills

Data analysis

Remote work ability

Education

Master's or Ph.D. in Pharmacy/Medicine/Life Sciences

Tools

Argus

ArisG

Job description

About the Role

Our client, a globally recognized pharmaceutical company with a significant presence in Quintana Roo , is seeking a highly skilled and motivated Pharmacovigilance Specialist to join their team, supporting operations remotely but with a connection to their Cancún hub. This critical role involves the continuous monitoring, detection, assessment, and prevention of adverse effects of medicinal products. You will be responsible for ensuring that all pharmacovigilance activities comply with international and local regulatory requirements. The ideal candidate will possess a strong scientific background, excellent analytical skills, and a keen eye for detail. This is an excellent opportunity to contribute to drug safety on a global scale while enjoying the flexibility of a remote role, supported by a leading entity in the pharmaceutical industry.

Key Responsibilities

• Collect, process, and evaluate adverse event reports from various sources, including healthcare professionals, patients, and clinical trials.
• Conduct thorough assessments of adverse event data to determine causality and potential safety signals.
• Prepare and submit regulatory reports on drug safety to health authorities in a timely and accurate manner.
• Develop and implement pharmacovigilance strategies and plans in accordance with regulatory guidelines.
• Monitor emerging safety trends and provide recommendations for risk management and mitigation strategies.
• Collaborate with internal departments (e.g., regulatory affairs, medical affairs, clinical development) and external partners to ensure comprehensive safety surveillance.
• Maintain accurate and up-to-date pharmacovigilance databases and records.
• Participate in the development and review of product labeling and regulatory submission documents.
• Contribute to the maintenance of the company's safety database and compliance systems.
• Stay abreast of evolving global regulatory requirements and industry best practices in pharmacovigilance.

Requirements

• Master's degree or Ph.D. in Pharmacy, Medicine, Life Sciences, or a related field.
• Minimum of 4 years of direct experience in pharmacovigilance or drug safety.
• Thorough understanding of international and local pharmacovigilance regulations (e.g., CIOMS, ICH, FDA, EMA).
• Experience with pharmacovigilance databases and safety reporting systems (e.g., Argus, ArisG).
• Strong analytical, critical thinking, and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to convey complex information clearly.
• Ability to work independently and manage multiple projects in a remote setting.
• Proficiency in data analysis and report generation.
• High level of integrity and attention to detail.
• Experience in the pharmaceutical or biotechnology industry is highly preferred.

Benefits

This remote position offers a highly competitive salary, comprehensive benefits package including health and life insurance, retirement contributions, and generous paid time off. You will have the opportunity to work with a leading pharmaceutical organization, contribute to critical drug safety initiatives, and enjoy the professional flexibility afforded by a remote work arrangement, with opportunities for professional development and continuous learning.