PV Associate (x2)

Are you passionate about ensuring the safety and efficacy of life sciences products? This is an exciting opportunity to join a dynamic team supporting the development and safety of innovative healthcare solutions. You will have the chance to make a real impact within a forward-thinking organization focused on pharmacovigilance and patient safety. If you thrive in a collaborative environment and are eager to grow your expertise, this role is perfect for you!

Our client is a growing leader in the life sciences sector, dedicated to advancing drug safety and regulatory compliance. They are seeking a Pharmacovigilance Associate to support their safety operations, ensuring accurate case processing and regulatory reporting. This role is essential in maintaining the highest standards of data integrity and safety compliance, directly impacting patient care and product reliability.

Role Summary
You will be responsible for processing adverse event reports, supporting safety database activities, and ensuring timely regulatory submissions. This on-site position offers the opportunity to work closely with cross-functional teams, such as Medical Affairs, Regulatory, and Quality assurance, contributing to the ongoing safety and success of the organization’s portfolio.

Key Responsibilities

• Lead case intake, triage, and data entry in the safety database, maintaining compliance with SOPs and regulations
• Manage medical coding using established coding dictionaries to ensure data accuracy
• Support timely regulatory reporting and distribution activities, including serious case assessments
• Conduct quality control to resolve data queries and maintain inspection-ready records
• Support reconciliation activities across clinical, medical, and partner sources to identify/discuss discrepancies
• Contribute to process improvements by tracking operational metrics and analyzing trends
• Collaborate cross-functionally for follow-up activities and query resolution
• Assist in preparing documentation for inspections or audits as needed
• Support safety data review meetings by preparing materials and documenting outcomes

Experience & Skills

• 1–2 years of hands-on experience in drug safety or pharmacovigilance
• Proficiency with safety databases and complete case workflow management
• Working knowledge of global pharmacovigilance regulations and guidelines
• Experience with medical coding and data quality assurance
• Excellent attention to detail, strong communication skills, and ability to manage multiple priorities
• A bachelor’s degree in life sciences, pharmacy, nursing, or related field