Pharmacovigilance Specialist – Case Processing

About the role

ProPharma is seeking a Pharmacovigilance Specialist focused on case processing to support the safety monitoring of clinical trial and post‑marketing products. The role involves managing individual case safety reports, assessing seriousness and expectedness, and ensuring timely regulatory submissions.

Key responsibilities

• Process adverse event cases daily, including MedDRA coding and determination of seriousness and expectedness.
• Conduct case follow‑up activities and gather additional information as needed.
• Draft and review comprehensive medical narratives for each case.
• Submit expedited reports to regulatory authorities in line with SOPs and global safety regulations.
• Provide client notifications and support training material development.
• Perform peer reviews to ensure case quality, consistency, and accuracy.

Required profile

• Bachelor’s degree in life sciences (advanced degree, RN, RPh, PharmD preferred).
• Minimum two years of experience in pharmacovigilance or related safety reporting.
• Strong attention to detail, problem‑solving ability, and capacity to work both independently and within a multidisciplinary team.

Required skills

• Proficiency in MedDRA coding.
• Basic knowledge of pharmacovigilance processes and regulations.