High-Demand Roles
Drug Safety Associate, PV Associate, Clinical Safety Scientist, PV Coordinator.
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Yrs. of Excellence
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Branches in HYD
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Why Pharmacovigilance is Critical for Pharma Careers
Pharmacovigilance is a non-negotiable requirement for drug manufacturing and distribution worldwide. As regulatory bodies like the FDA and EMA increase scrutiny, qualified PV professionals are essential.
This course trains you in the core competencies of case processing, safety reporting, and regulatory affairs documentation, enabling you to play a vital role in patient safety and compliance.
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Pre-Requisites for Pharmacovigilance
Eligibility
Who Can Attempt This Course?
Detailed Pharmacovigilance Curriculum
The training covers the entire PV lifecycle, from adverse event collection to global reporting standards. Our Expert Instructors use case studies to ensure a balance between theoretical knowledge and real-world experience.
Introduction to PV & Regulations
Principles of drug safety monitoring, historical context, and the roles of regulatory agencies (FDA, EMA).
ICSR Case Processing
Case intake, data entry, causality assessment, and narrative writing (using industry databases like Clinevo, Oracle Argus/ARISg).
Global Safety Reporting
Mastering individual case safety reports (ICSRs), periodic safety update reports (PSURs), and rapid reporting requirements.
Medical Coding
Introduction to industry standard dictionaries: MedDRA coding for adverse events and drug terms.
Audits & Compliance
Ensuring compliance with ICH-GCP guidelines and preparation for regulatory audits and inspections.
Why Choose Stansys?
Our Unmatched Commitment to Your Success
Frequently Asked Questions (FAQs)
Is a pharmacy background required for this course?
While a B.Pharm or M.Pharm is ideal, degrees like B.Sc. and M.Sc. (Life Sciences) are also eligible. The key is a strong commitment to learning the scientific and regulatory aspects of drug safety monitoring.
What job roles can I get after completing this training?
Graduates are typically prepared for roles like Drug Safety Associate, Case Processor, and Clinical Safety Scientist at CROs, pharmaceutical companies, and IT companies with dedicated PV verticals.
How does Stansys help with job placement?
We provide 100% Job Assistance, including comprehensive training, specialized resume preparation for the PV domain, mock interviews simulating client-side screenings, and access to our network of recruitment partners.
What are the class delivery options for this course?
We offer maximum flexibility with Live Classes through our traditional Classroom Training in our centers (SR Nagar, Ameerpet, etc.) and comprehensive On-line Training solutions.
Do you cover regulatory guidelines like ICH-GCP?
Yes, a major component of the training covers global regulatory requirements, including the guidelines set by ICH-GCP, FDA, and EMA, which is essential for compliance and global job readiness.
What kind of support do students receive?
Students benefit from continuous 24 X 7 Support from our team, ensuring they have assistance with practical exercises, case studies, and any technical queries related to the course materials.
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