Job Title: Senior Clinical Research Trainer Advanced Level (Pharmacovigilance & Clinical Data Management Expert) Experience Required: 10+ years Location: Pune Employment Type: Full-time Salary Range: As per Industry Standard Job Summary: We are seeking an experienced and dynamic Senior Clinical Research Trainer to lead advanced training programs in clinical research domains including Pharmacovigilance (PV) , Clinical Data Management (CDM) , and Regulatory/Clinical Guidelines . The ideal candidate will have over 10 years of industry experience and a strong track record of mentoring professionals, designing curriculum, and ensuring industry-aligned learning outcomes. Key Responsibilities: Training Delivery & Development Design and deliver advanced-level training modules in Clinical Research, Pharmacovigilance , Clinical Data Management , and GCP, ICH, USFDA, EMA guidelines. Conduct both theoretical and hands-on training sessions using real-world case studies, tools, and systems (e.g., Argus, ArisG, iMedidata, eTMF, Viva Vault, Oracle Clinical, MedDRA, CDISC). Develop assessments, workshops, and continuous learning tools to measure trainee progress. Curriculum & Content Creation Regularly update training material based on evolving industry standards , regulatory changes , and best practices . Integrate mock projects and case-based scenarios to simulate real clinical research environments. Mentoring & Evaluation Mentor and support trainees pursuing careers in clinical research, PV, or CDM roles. Provide feedback and performance evaluations to ensure skill development and job readiness. Industry Collaboration Engage with clinical research organizations (CROs), hospitals, pharma companies, and academic partners for knowledge exchange, guest lectures, or internship support. Compliance & Quality Ensure all training adheres to GCP , 21 CFR Part 11 , ICH E6 , and company/industry SOPs . Curriculum Development & Training Delivery Create modular, outcome-based training sessions for various roles within clinical trials (e.g., CRCs, CRAs, investigators). Customize content for in-person and virtual formats, incorporating PV and CDM where relevant. Develop quizzes, case studies, and role-play exercises to enhance applied learning. Pharmacovigilance & CDM Integration Explain pharmacovigilance systems (e.g. E2B, MedDRA coding) and signal detection workflows to trainees. Provide hands-on guidance in adverse event reporting, causality assessments, and regulatory submissions. Train learners on clinical data lifecycle—from CRF design and eCRF tools to data validation and database lock. Regulatory & Compliance Coaching Teach ICH-GCP, Schedule Y, NDCT rules 2019, ICMR, ICH E6 and global trial protocols with emphasis on ethics and patient safety. Conduct sessions on regulatory documentation (e.g., IBs, protocols, SOPs). Keep trainees up-to-date with evolving guidelines (e.g. EU CTR, FDA CFR, CDSCO policies). Facilitation & Engagement Lead interactive discussions, practical demonstrations, and Q&A sessions to clarify complex topics. Mentor new trainers and support onboarding of junior clinical research staff. Encourage critical thinking and professional development through ongoing support. Evaluation & Feedback Assess trainee comprehension using structured tools like pre/post assessments and scenario analysis. Provide individualized feedback to learners and suggest learning pathways for skill enhancement. Analyze training effectiveness and recommend improvements to management. Qualifications Master's or PhD in Medical Sciences, Pharmacy, Life Sciences, or a related field. Minimum 10 years of professional experience in Clinical Research. Strong working knowledge of Pharmacovigilance and Clinical Data Management preferred. Proven track record of conducting successful training programs. Excellent communication and presentation skills. Ability to simplify complex concepts and engage learners at all levels. Key Requirements: Education: Master’s degree or higher in Pharmacy, Life Sciences, Clinical Research, or related field. Experience: 10+ years of professional experience in clinical research , with deep hands-on expertise in Pharmacovigilance and Clinical Data Management . Certifications Preferred: GCP Certification, PV/CDM Certification, or equivalent training credentials. Capable of handling interactive role-play and case-based scenarios. Attention to detail, adaptability, and team collaboration. Technical Skills: Tools: Oracle Argus , Oracle Clinical , MedDRA , WHO Drug , EDC systems (e.g., Medidata, Inform) Documentation: ICF, SOPs, SAE Reports, Data Clarification Forms (DCF) Guidelines: In-depth knowledge of ICH-GCP , FDA , EMA , and Schedule Y, NDCT 2019 Data Standards: Familiarity with CDISC , SDTM , ADaM Soft Skills: Excellent verbal and written communication Strong organizational and mentoring abilities Analytical thinking and problem-solving skills Ability to simplify complex concepts for diverse learners Preferred Qualities: Prior experience in corporate training , academic instruction , or clinical research consultancy Ability to create engaging e-learning content or lead LMS-driven programs Published work or conference presentations in the clinical research field is a plus