25 oct
|
Placements24
|
Cancún
25 oct
Placements24
Cancún
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 general 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.
📌 Especialista en Farmacovigilancia en Cancún
🏢 Placements24
📍 Cancún