Patient Safety Associate II / Patient Safety Specialist

Parexel; Sahibzada Ajit Singh Nagar; Vor Ort; INR 800.000 - 1.200.000; Vollzeit

Zusammenfassung

Parexel is seeking a Patient Safety Associate II/Specialist for a nine-month on-site contract. You will support pharmacovigilance activities, safety case processing, regulatory submissions, literature surveillance, and compliance with international regulations.

This role involves collaboration with cross-functional teams and affiliates to ensure timely safety deliverables. Ideal candidates have a pharmacy or life sciences background, 2+ years in safety or regulatory roles, and strong knowledge

Qualifikationen

• Bachelor's degree in Pharmacy, Nursing, Life Sciences or related field.
• 2+ years in safety case management or regulatory reporting.
• Knowledge of ICH-GCP and pharmacovigilance requirements.
• Proficiency with safety databases and data analysis tools.

Aufgaben

• Process safety reports and ensure regulatory compliance.
• Manage safety case processing workflows including coding and causality assessment.
• Submit ICSR and periodic report submissions to authorities.
• Conduct literature searches for adverse drug reactions and identify safety signals.
• Coordinate with global teams and local affiliates on pharmacovigilance requirements.
• Assist with QA, data reconciliation, and metrics reporting.

Kenntnisse

Safety case management

Regulatory reporting

ICH-GCP familiarity

Pharmacovigilance systems

Data analysis

Ausbildung

Bachelor's degree in Pharmacy or health sciences

Tools

Safety databases

Jobbeschreibung

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.

About The Role

We are 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

You’ll Thrive In This Role If You Bring

• 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

Required Qualifications

• 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

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.