Specialist Pharmacovigilance Professional

Job Overview

This role involves specialized pharmacovigilance duties within a hybrid working framework supporting pharmaceutical research and development aimed at ensuring safe and effective medication use. The position focuses on evaluating safety data, collaborating cross-functionally to improve patient safety outcomes, and ensuring adherence to regulatory standards.

Key Responsibilities

• Conduct comprehensive case-related pharmacovigilance tasks supporting ongoing pharma R&D and guarantee timely safety reporting to regulatory authorities.
• Examine clinical and post-marketing safety reports to detect potential safety signals and aid in patient risk assessments.
• Analyze safety datasets with organizational tools to identify trends or patterns, escalating pertinent observations to medical safety teams.
• Accurately document all case handling activities to allow clear audits and inspection processes internally and externally.
• Work alongside multi-disciplinary R&D teams to incorporate safety insights into study planning and product lifecycle decisions fostering therapeutic advances.
• Coordinate with quality assurance and compliance functions to adhere to current pharmacovigilance protocols and support continual SOP improvements.
• Assist in developing safety-related sections for regulatory submissions and routine reports ensuring clear communication of product safety.
• Share knowledge in internal meetings to promote uniform case processing and enhance the pharmacovigilance expertise within the company.
• Collaborate with IT and data divisions to optimize pharmacovigilance systems improving data handling efficiency and reliability.
• Participate in compliance audits and readiness checks by supplying case documentation evidencing strict regulatory adherence.
• Adapt to hybrid work environments leveraging digital collaboration to ensure uninterrupted pharmacovigilance functions across remote and onsite settings.
• Contribute to broader organizational aims by converting safety data into actionable insights that support responsible medication use and public health welfare.
• Manage workload effectively during day shifts, ensuring all assigned safety tasks and schedules are completed on time without travel requirements.

Qualifications and Skills

• Bachelor’s degree or higher in life sciences, pharmacy, medicine, or a related scientific field providing a robust foundation in drug safety evaluation.
• 2 to 4 years of specialized experience in pharmaceutical R&D with hands-on involvement in pharmacovigilance operations.
• Proficiency with safety data review tools/databases to efficiently handle case processing maintaining data quality and traceability.
• Knowledge of pharmacovigilance data management for precise entry, reconciliation, and retrieval of safety information.
• Understanding of pharmacovigilance case processing workflows including intake, coding, assessment, and follow-ups compliant with current regulatory standards.
• Excellent communication skills to articulate complex safety topics clearly to global stakeholders in both written and verbal formats.
• Dedication to continuous professional development relating to updates in pharmacovigilance regulations and methodologies.

Certifications

Preference given to candidates holding recognized pharmacovigilance or drug safety professional certifications.