Clinical Research & Pharmacovigilance Trainer

Job Title:

Location:

Employment Type:

About Biotecnika

Indias largest & oldest biotech career and education platform

Role Overview:

dynamic Clinical Research (CR) and Pharmacovigilance (PV) professional

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).