We are HCLTech, one of the fastest-growing large tech companies in the world and home to 224,000+ people across 60 countries, supercharging progress through industry-leading capabilities centered around Digital, Engineering, Cloud, AI and software, powered by a broad portfolio of technology services and products.

Job Summary: Responsible for participating in adverse event case management,to include assisting the Senior Safety Scientist and Program Manager in client related Adverse Event Management activities, processing cases under the single case ownership models as to remain current with the activity and compliant with regulatory timelines. The Safety Scientist supports clients on assigned team or teams, depending upon volume and case complexity, and resolves issues and works with the Project Physician and Program Manager to consistently assess case quality and establish plans and actions for improvements.

Essential Job Function:

• Assisting with Project Planning: Helping in the preparation of project plans as required.
• Monitoring Compliance: Alerting the Program Manager when activities fall outside the Statement of Work (SOW) and ensuring that all internal and client-specific activities are performed in compliance with appropriate regulatory requirements.
• Processing and Evaluating Adverse Event (AE) Reports: Following standard operating procedures (SOPs) to process and evaluate AE reports, including writing narratives and performing seriousness, causality, and expectedness assessments.
• Ensuring Data Quality and Accuracy: Ensuring the quality and accuracy of data used to support regulatory documents, including Individual Case Safety Reports (ICSRs), aggregate data, and line listings.
• Training and Mentoring: Preparation of safety-specific training materials, leading training sessions, and mentoring and updating new and existing staff.
• Data Reconciliation: Assisting in the reconciliation of clinical and safety databases.
• Signal Detection and Assessment: Contributing to the preparation and quality control of safety aggregate reports, responses to authorities, and signal detection and assessment.
• Literature Review: Performing literature reviews to identify case reports and other relevant safety information.
• System Evaluation and Validation: Assisting in the evaluation and validation of systems to support safety operations.
• Case Triage and Management: Performing triage of cases prior to processing and informing appropriate staff of any issues to assure patient safety.
• Regulatory and Compliance Roles: Functioning in roles such as Deputy Qualified Person for Pharmacovigilance (deputy QPPV), Responsible Person (RP), and participating in quality assessment reviews and audits.
• Privacy and Data Protection Management: Functioning as the PV Data Protection Officer (DPO) and providing support to the Global Privacy Office for various aspects of the privacy program, including privacy baseline controls implementation, privacy impact assessment program, and privacy incident management.
• Risk Management: Facilitating accurate evaluation of privacy risks, devising risk remediation strategies, and coordinating with business engagement and corporate functions on privacy and data protection matters.

Job Requirements: Education/Experience:

• Minimum of a Bachelor’s Degree or equivalent healthcare licensure (e.g., MD, RN, PharmD, RPH, or NP).
• Preferably, experience from bio-pharmaceutical organizations, drug safety, or other service providers based on client demands.
• Clinical background with experience in various therapeutic areas may be required.
• Ability to handle high case volume and complex cases.
• Pharmacovigilance (PV) experience, including safety system experience, case processing, and interfacing with global safety teams.
• Clinical trial and post-marketing experience preferred.
• Computer Technical Skills: Proficiency in MS Excel, Word, PowerPoint, and previous safety database experience preferred.
• Teamwork: Works collaboratively, listens actively, and engages constructively.
• Builds strong relationships with leadership, team members, and clients.
• May require travel to training sessions and certification.

What we offer:

• Competitive salary and performance bonuses
• Social benefits package
• Additional health insurance
• Hybrid model of working
• Referral bonus
• Learning hub
• Team buildings and company events
• Career growth

The driving force behind that work, our people are diverse, creative, and passionate, raising the bar for excellence on a regular basis. We, in turn, work hard to bring out the best in them as we strive to help find their spark and become the best version of themselves. Join our team now!