Pharmacovigilance Specialist

We are looking for a dedicated and detail-oriented Pharmacovigilance Specialist to join our growing team. You will be responsible for monitoring, collecting, and reporting adverse events, maintaining drug safety data, and ensuring compliance with pharmacovigilance requirements. This role is based in Ho Chi Minh City.

The ideal candidate will have a background in pharmacy or life sciences, strong attention to detail, and the ability to work closely with medical, regulatory, and internal teams to ensure patient safety and regulatory compliance.

Key Responsibilities:

1.Adverse Event Reporting:

• Collect, evaluate, and report adverse events (AEs) from healthcare professionals, patients, or other sources.
• Ensure timely submission of pharmacovigilance reports to regulatory bodies (e.g., FDA, EMA).
• Maintain a Pharmacovigilance System Master File (PSMF) if required by regulations.

2.Risk Management:

• Develop and implement Risk Management Plans (RMPs) for marketed products.
• Analyze risk-benefit profiles and provide recommendations to management and regulatory authorities.

3.Compliance with Regulations:

• Ensure compliance with local and international pharmacovigilance regulations and guidelines (e.g., ICH E2E, GVP, FDA regulations).
• Stay updated on global pharmacovigilance regulations and industry best practices.

4.Signal Detection & Risk Evaluation:

• Analyze adverse event data to detect new safety signals.
• Conduct benefit-risk assessments and communicate findings to stakeholders.

5.Safety Data Management:

• Ensure accurate data collection, storage, and reporting of safety information.
• Use pharmacovigilance databases (e.g., ARGUS, Veeva Vault QMS, or similar systems) for managing safety data.

6.Collaboration & Communication:

• Collaborate with medical affairs, regulatory affairs, and clinical development teams to ensure integrated safety management.
• Communicate safety issues clearly to internal teams, health authorities, and healthcare providers.

7.Training and Awareness:

• Train other employees (e.g., medical teams, sales representatives) on pharmacovigilance processes and reporting mechanisms.

8.Audits & Inspections:

• Prepare for regulatory audits and inspections related to pharmacovigilance.
• Ensure that the pharmacovigilance system is continuously audited for compliance.

Required Skills & Qualifications:

Education:

• Minimum Requirement: A Bachelor's degree in Pharmacy, Medicine, or a related scientific field.
• Preferred: A Master’s degree or Ph.D. in a relevant discipline (e.g., Pharmacology, Toxicology, Pharmaceutical Sciences).
• Additional qualifications or certifications in Pharmacovigilance or Drug Safety (e.g., Drug Safety Associate Certification, ICH-GCP).

Experience:

Junior/Entry-Level (Pharmacovigilance Specialist):

• 0-3 years of experience in pharmacovigilance or a related field (e.g., clinical research, regulatory affairs).
• Familiarity with adverse event reporting systems and databases.

Key Competencies:

Knowledge of Pharmacovigilance Regulations:

• Familiarity with global pharmacovigilance guidelines such as ICH E2E, Good Pharmacovigilance Practices (GVP), and local regulatory requirements.

Data Analysis Skills:

• Proficiency in signal detection, trend analysis, and statistical analysis related to drug safety.