Career Opportunity: Patient Safety Associate II / Specialist at PAREXEL

PAREXEL is currently seeking qualified professionals for a temporary 9-month contract assignment as a Patient Safety Associate II / Specialist within their Patient Safety Operations team. As a leading global biopharmaceutical service provider, PAREXEL supports the biotechnology and pharmaceutical industries by facilitating the development of new treatments and drugs worldwide through contract research, medical consulting, and specialized services.

Key Responsibilities

Safety Report Processing: Monitor, process, and assess incoming safety reports from diverse sources while performing data entry and quality validation to maintain accuracy and compliance.
Case Management Workflows: Execute comprehensive safety case processing workflows, which include MedDRA coding, causality assessment, expectedness determination, and the preparation of narratives and case documentation.
Regulatory Submissions: Handle Individual Case Safety Reports (ICSR) and periodic report submissions to regulatory authorities in adherence to global reporting timelines.
Literature Surveillance: Implement effective literature search strategies, screen publications to identify adverse drug reactions, spot potential safety signals, and ensure alignment with international pharmacovigilance regulations.
Affiliate Coordination: Support communication between global safety operations and local affiliates, assisting with health authority interactions and country-specific regulatory needs.
Quality Assurance & Compliance: Participate in data reconciliation, metrics collection, quality assurance activities, and the management of regulatory applications and product lifecycle changes.
Regulatory Intelligence: Research and disseminate regulatory intelligence updates to internal teams and clients while contributing to the creation of standard operating procedures.

Candidate Profile & Qualifications

Education: Bachelor’s degree in Pharmacy, Nursing, Life Sciences, Health Sciences (e.g., Biomedical Sciences, Microbiology, Biochemistry, Biotechnology, Dentistry), or an equivalent qualification/work experience.
Experience: Minimum of 2 years of professional experience working in safety case management, regulatory reporting, or broader pharmaceutical and healthcare environments.
Core Competencies: Strong analytical thinking, problem-solving, attention to detail, clear communication skills, and a patient-focused commitment to regulatory compliance.
Technical Knowledge: Familiarity with ICH-GCP guidelines, clinical trial processes, regional pharmacovigilance requirements, safety databases, and MS Office applications.
Preferred Qualifications: Advanced degrees or professional certifications in regulatory affairs or pharmacovigilance, experience with systems like EudraVigilance and eCopy, and background in global or multi-regional environments.