Career as Patient Safety Associate / Specialist at PAREXEL

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.

Post : Patient Safety Associate II / Patient Safety Specialist

Job Description
• Seeking a Patient Safety Associate II/Specialist to join our Patient Safety Operations team in a Temporary assignment (Contract role for 9 months) for on-site capacity. As a Patient Safety Associate II/Specialist, you will support global pharmacovigilance activities that advance new treatments for patients. This position plays a key role in safety case processing, regulatory submissions, literature surveillance, and compliance with international regulations. You will collaborate with cross-functional teams, follow industry-standard processes, and contribute to safety operations from study initiation through closeout.
• Responsibilities include processing safety reports, executing regulatory submissions, conducting literature reviews, coordinating with affiliates, and supporting regulatory intelligence activities. You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through ensuring patient safety and regulatory compliance. With diverse teams and continuous learning opportunities, the Patient Safety Associate II/Specialist can explore career paths and expand skills across global pharmacovigilance and clinical research

Key Responsibilities
• Monitor, process, and assess incoming safety reports from various sources, performing data entry and quality validation to ensure accuracy and compliance with regulatory standards
• Execute safety case processing workflows including MedDRA coding, causality assessment, expectedness determination, and preparation of case documentation and narratives
• Execute ICSR and periodic report submissions to regulatory authorities, maintaining compliance with global reporting timelines and regulatory requirements
• Implement literature search strategies, screen publications for adverse drug reactions, identify potential safety signals, and maintain alignment with global pharmacovigilance regulations
• Support communication and coordination between global safety operations and local affiliates, assisting with local health authority interactions and country-specific pharmacovigilance requirements
• Conduct quality assurance activities, perform data reconciliation, and participate in metrics collection and reporting to support continuous improvement initiatives
• Manage regulatory applications and product lifecycle changes in safety databases, supporting global regulatory activities across multiple regions
• Research and disseminate regulatory intelligence to internal teams and clients, maintaining a centralized repository of regulatory updates and contributing to development of standard operating procedures
• Collaborate with cross-functional teams and clients, attending meetings and coordinating activities to ensure timely delivery of safety deliverables
• Develop and maintain knowledge of safety profiles, labeling, global regulations, and internal procedures while following documentation and archiving standards

Skills
• Strengths in analytical thinking, problem-solving, and attention to detail
• Experience working in pharmaceutical, healthcare, or a regulated environment
• The ability to collaborate across teams and communicate clearly with internal and external stakeholders
• A patient-focused mindset and commitment to quality and regulatory compliance
• Comfort working with pharmacovigilance systems, databases, and MS Office applications
• Strong organizational and time management capabilities with the ability to manage multiple priorities

Candidate Profile
• Bachelor's degree in Pharmacy, Nursing, Life Sciences, Health Sciences, or other health-related field (e.g., Biomedical Sciences, Microbiology, Biochemistry, Biotechnology, Dentistry), or equivalent qualification/work experience
• 2+ years of experience in safety case management, regulatory reporting, or pharmaceutical/healthcare environments
• Knowledge of ICH-GCP guidelines, regional pharmacovigilance requirements, and clinical trial processes
• Proficiency with safety databases and data analysis tools
• Strong communication, organization, and problem-solving skills

Preferred Qualifications
• Advanced degree or professional certification in pharmacovigilance or regulatory affairs
• Experience with EudraVigilance, eCopy, or other pharmacovigilance systems
• Familiarity with regulatory submission processes and portal/gateway systems
• Experience in a global or multi-regional pharmacovigilance environment

Additional Information
Qualification : Bachelor's degree in Pharmacy, Nursing, Life Sciences
Experience : 2+ years
Job ID : R0000045019
Primary Location : India, Mohali
Additional Locations : India, Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th September 2026