Clinical Research & Pharmacovigilance Trainer

Job Title: Trainer Clinical Research & Pharmacovigilance

Location: Bangalore (Remote)

Employment Type: Full-time

About Biotecnika

Biotecnika is Indias largest & oldest biotech career and education platform, dedicated to empowering students, researchers, and professionals in the life sciences domain. With 19+ years of expertise, we provide cutting-edge courses, industry collaborations, and hands-on training to help aspiring biotech professionals succeed.

Role Overview:

We are seeking a dynamic Clinical Research (CR) and Pharmacovigilance (PV) professional to develop and deliver training programs for students and professionals. The trainer will be responsible not just for teaching, but also for designing the complete course curriculum, delivering interactive classes, and creating engaging learning materials. The goal is to prepare students for real-world industry roles in Clinical Research and Pharmacovigilance, with a strong understanding of regulatory and compliance frameworks.

Key Responsibilities:

• Develop and update comprehensive course content, including PowerPoint presentations, assessments, interactive quiz and assignments for biotech, pharmaceuticals, clinical research and chemical industries and ensure the course aligns with current industry standards and best practices.
• Deliver interactive online classes and engaging lectures on Clinical research & Pharmacovigilance to students and professionals.
• Mentor students during project work and guide them in applying CR and PV knowledge to real-life scenarios.
• Stay updated with PV & CR industry databases & tools (e.g., MedDRA, WHO drug dictionary, WHO Vigiflow, Argus, Aris G, EDC systems like Castor/OpenClinica/ Veeva Vault, AI tools), trends, and global regulatory guidelines (US FDA, EMA, CDSCO, MHRA,WHO etc.).
• Provide virtual hands-on training using simulations, case studies, and freely available tools/templates relevant to CR & PV ensuring hands-on learning and real-world exposure.
• Collaborate with internal teams for continuous improvement in training delivery and content quality.
• Mentor students on career pathways in CR & PV.
• Provide support through doubt-clearing sessions and career guidance.
• Assess student performance through quizzes, projects, and exams, and provide constructive feedback.
• Create content for YouTube shorts & videos, reference articles, reading material, eBooks, and participate in webinars and workshops as required.
  
  

Qualifications & Experience:

Essential:

• Ph.D. in Life Sciences, Biotechnology, Pharmacy, or Clinical Research with Minimum 2 years of core industry experience in clinical research, clinical trial management, or pharmacovigilance.
• Masters in Life Sciences, Biotechnology, Pharmacy, or Clinical Research with minimum 5 years of core industry experience in clinical research, clinical trial management, or pharmacovigilance.
• Strong knowledge of ICH-GCP guidelines, regulatory frameworks, and clinical trial protocols.
• Knowledge on CR & PV related free tools/databases/AI tools/softwares (eg: clinical trials.gov, PV databases (MedDRA & WHO drug dictionary), PV tools such as Vigiflow, Argus/Oracle safety, Aris G, Vigilance Tools, EDC systems, Power BI/ Tableau Public/Knime, OpenFDA API, PubChem API).
• Explain core concepts such as drug discovery & development lifecycle, clinical trials phases, conduct and operations, adverse events, Case report forms, regulatory submissions, RMPs, data management, data analysis and audit processes.
• Prior teaching/training experience in CR , PV or related fields.
• Ability to simplify and explain complex concepts in a learner-friendly manner.
• Excellent communication, presentation, and mentoring skills.
• Familiarity with MS Office and online teaching platforms (Zoom, Google Meet, LMS tools, etc.).

Desirable:

• Industry experience in clinical trial management, CROs, or pharmaceutical R&D.
• Knowledge on AI Tools used in CR protocol design (clinical research trials, data visualization, cleaning, preprocessing and data handling (eg: using EDC systems like Castor, SAS/SPSS/R/Python Basics, Google Collab, etc.).
• Knowledge on PV databases (MedDRA), software tools, Vigilance Tools & AI tools in PV.
• Certification in Clinical Research (e.g., CCRP, ACRP, DIA).