Safety Technology Analyst
Parexel
IndiaremotePosted 14 days ago
Skill Required
Safety-Technology-AnalystDrug-Safety-SpecialistPharmacovigilance-AnalystPV-SpecialistClinical-Data-AnalystSafety-AnalystSenior-Safety-Technology-EngineerSenior-Technology-Safety-SpecialistSafety-AnalyticsSystem AdministrationITILEngineeringanalyticaldevelopingsecuritywrittenTestNGdesignAgileSQLGCPandAIFulltime
Key highlights
- Required experience: 2+ years in safety supportive applications
- Must be fluent in English with technical writing skills
- Knowledge of 21 CFR Part 11 and computer system regulations required
- Preferred qualifications include a BA/BSc in Engineering or Computer Science
- Parexel has 22,000+ employees worldwide
- Role involves cross-functional collaboration and regulatory compliance
Role overview
We are seeking a Safety Technology Analyst (STA) to join our team. As a Safety Technology Analyst, you will support critical pharmacovigilance operations and safety database management that advance patient safety and regulatory compliance. This position plays a key role in safety technology support, system administration, regulatory adherence, and operational excellence. You'll collaborate with cross-functional teams across Safety Services, IT, Quality, and external clients, follow industry-standard processes, and contribute to safety operations from study setup through closeout.
Responsibilities
- Conduct setup and support activities for Parexel safety databases and associated systems, including new study configuration, periodic and ad-hoc report generation, expedited report rule configuration, and comprehensive end-user support
- Support the planning and delivery of safety database handovers from client to Parexel when taking over pharmacovigilance operations, and from Parexel to client at study closeout
- Contribute to the development and maintenance of standard operating procedures and controlled documents related to safety technology systems
- Support the delivery of integration solutions between Parexel safety technologies and other applications to enhance operational efficiency and service capabilities
- Represent Safety Technology Management with cross-functional Parexel teams (TQM, QA, IT) and external auditors to ensure adequate management of database systems, hardware, network security, quality standards, and project services
- Collaborate with Parexel IT, vendors, Safety Services staff, and clients to analyze, resolve, and close technical issues for supported systems
- Support change management activities including impact assessments, testing methodologies, system validation, and software updates in accordance with Software Development Life Cycle standards
- Provide training and mentoring to new or developing staff on safety technology systems and support activities
- Ensure adherence to pharmaceutical regulations including 21 CFR Part 11 compliance, computer system validation, and quality standards
Requirements
- 2+ years of experience in all functional areas of safety supportive applications (Argus, Vault Safety, EDC, Safety ERP) including secondary tools and processes
- 2+ years of experience working closely with operational teams to manage issues, gather requirements, and deliver safety business process solutions
- Demonstrated experience with computerized system validation methodologies and processes
- Fluent in English with demonstrated ability to write technical documentation and deliver clear presentations to stakeholders
- Experience supporting team members through peer oversight, coaching, and training
- Strong interpersonal, verbal, and written communication skills with the ability to work effectively across matrix teams
- Intermediate system administration and application support skills in pharmacovigilance safety technology (safety databases, gateway/E2B, report development, or signal detection)
- Intermediate technical writing capability and experience with industry-standard Service Desk Tools
- Analytical and problem-solving skills with a client-focused approach and strong attention to detail
- Experience with software development lifecycle (SDLC) processes, change management, and Agile methodology
- Knowledge of computer system regulations including 21 CFR Part 11, EMA Annex 11, and GAMP guidelines
- Intermediate knowledge of pharmacovigilance roles, standards, practices, GVP, and GCP
- Intermediate SQL scripting skills and interest in emerging pharmacovigilance safety technologies including AI
- Flexible attitude toward work assignments, new learning, and ability to manage multiple tasks with enthusiasm
Nice to have
- BA/BSc in Engineering or Computer Science; master’s degree or equivalent preferred
- Demonstrable participation in system or process improvement initiatives
- Experience working with cross-functional teams as a safety technology representative
Additional details
- When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
- Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
- 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(R).
- 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.
- If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be perfect fit, send them the link to apply!
- Originally posted on Himalayas