Wanted Trainer For Cr, Pv, Cdm And Regulatory Affairs
- Resolve Medicode
- 3 - 6 years
- Delhi, NCR
- 6 months ago
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Job Description
Job Summary
We are seeking a highly skilled and experienced professional to train and mentor students/professionals in **Clinical Research, Pharmacovigilance, Clinical Data Management, and Regulatory Affairs**. The ideal candidate will have strong domain expertise, practical industry experience, and the ability to deliver interactive and engaging training sessions aligned with current industry standards and regulatory guidelines.
Key Responsibilities
Training & Facilitation
Design, develop, and deliver training modules for Clinical Research, Pharmacovigilance, Clinical Data Management, and Regulatory Affairs.
Provide theoretical and practical knowledge through case studies, live project examples, and simulation exercises.
Conduct assessments, quizzes, and evaluations to measure learning outcomes.
Curriculum Development
Update training materials in line with ICH-GCP, USFDA, EMA, CDSCO, and other global regulatory guidelines.
Incorporate latest industry trends, technology tools, and compliance requirements into the syllabus.
Clinical Research
Train on clinical trial phases, study design, protocol development, ethics, informed consent, and trial monitoring.
Explain roles of CROs, sponsors, and investigators.
Pharmacovigilance
Teach ADR reporting, signal detection, risk management, safety data analysis, and regulatory submissions.
Demonstrate usage of safety databases (e.g., Argus, ARISg).
Clinical Data Management**
Train on CRF/eCRF design, database management, query handling, data cleaning, and validation.
Explain CDISC standards and EDC systems.
Regulatory Affairs
Guide on regulatory submission processes, dossier preparation, and market authorization requirements.
Train on CTD/eCTD formats, product registration, and post-approval compliance.
Student/Participant Support
Provide mentorship, career guidance, and interview preparation.
Address queries and doubts effectively, ensuring student satisfaction.
Requirements
* Bachelors/Masters degree in Life Sciences, Pharmacy, Medicine, or related field.
* Minimum 35 years of industry experience in at least two of the following areas:
* Clinical Research
* Pharmacovigilance
* Clinical Data Management
* Regulatory Affairs
* Prior experience in training/mentoring preferred.
* Strong knowledge of ICH-GCP and global regulatory guidelines.
* Excellent communication, presentation, and interpersonal skills.
* Proficiency in MS Office and relevant industry tools/software.
Key Skills
* Domain expertise in Clinical Operations, PV, CDM, and Regulatory Affairs.
* Strong analytical and problem-solving skills.
* Ability to simplify complex topics for learners.
* Up-to-date knowledge of industry trends and regulations.
Salary & Benefits
* Competitive salary based on experience.
* Performance incentives and annual appraisals.
* Professional development and certification opportunities.
For Details share your Updated CV or Reach me
Princia
96779 44477
Job Classification
Industry: Education / TrainingFunctional Area / Department: Healthcare & Life SciencesRole Category: Other Hospital StaffRole: Patient Service AssistantEmployement Type: Full timeContact Details:
Company: Resolve MedicodeLocation(s): Delhi, NCR
Keyskills: Clinical Research Clinical Data Management Clinical Trials Regulatory Affairs Medical Writing Drug Safety Pharmacovigilance
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