Senior Patient Safety Specialist

Responsibilities

• Lead pharmacovigilance activities including ICSR processing, safety submissions, and regulatory intelligence to ensure global drug safety compliance.
• Coordinate ICSR processing workflows, including case assessment for seriousness, causality, and expectedness.
• Manage case documentation, narratives, reconciliation, and quality control processes.
• Execute ICSR and periodic report submissions to global health authorities with expert-level proficiency.
• Develop and maintain comprehensive literature search strategies and screen publications for adverse drug reactions.
• Serve as a primary liaison between global safety operations and local affiliates to ensure country-specific compliance.
• Research and maintain drug/device safety reporting regulatory intelligence and disseminate actionable updates to internal teams.
• Provide technical guidance and mentorship to junior team members and support continuous process improvement.

Requirements

• Degree in Pharmacy, Nursing, Life Science, or another health-related field.
• Proven experience in safety case management and regulatory reporting.
• Proficiency with pharmacovigilance systems and safety databases.
• Strong knowledge of ICH guidelines and regional drug safety regulations.
• Excellent analytical, problem-solving, and communication skills.

Preferred Qualifications

• Experience in pharmaceutical or healthcare environments.
• Demonstrated ability to mentor staff and lead process improvement initiatives.
• Expertise in managing regulatory applications and product lifecycle changes.

Benefits

• Flexible Work Program to support personal needs and work-life balance.
• Professional and personal development opportunities through continuous learning.
• "Bravo" Recognition Program to celebrate employee achievements.
• Supportive company culture focused on well-being and patient care.

About the Company

Parexel is a global leader in clinical research, dedicated to improving patient lives through innovative medical science and strategic clinical trial management. We prioritize a patient-first approach and foster an inclusive, compassionate, and results-driven work culture.