Gratisol Labs is India’s leading Pharmacovigilance Course Training Institute based in Hyderabad, Bangalore, Pune and Mumbai.
Those who are seeking a role in drug safety or pharmacovigilance should hold a life sciences, pharmacy or medical degree.
What is Pharmacovigilance (Pv)?
Pharmacovigilance monitors the safety of a drug once it has been launched onto the market. It is the process which improves the safety of medicines. It detects medicines that cause serious adverse drug reactions (ADRs) and ensures they are re-evaluated or removed from the market to protect public health.
Why is Pharmacovigilance Course Certification important?
Pharmacovigilance inspectors across the globe have rights conferred under the Medicines Act 1968 sections 111(1 to 3) and 112 (1 to 4 and 7). These include the right to enter any premises covered by the Act to carry out inspections, and take copies of Pharmacovigilance compliance documentation. In the US, if the FDA is unsatisfied with an inspection, they have powers to seize product, issue sizeable fines and even launch criminal proceedings.
Our course certificate enables you to quickly demonstrate that your staff has undergone the appropriate training and helps show that your company has appropriate pharmacovigilance systems in place.
Who can be inspected?
Depending on location, different legislation governs adverse drug reaction reporting within clinical trials and under post-marketing conditions. For example pharmacovigilance within clinical trials is governed by Directive 2001/20/EC – Volume 10 in the EU, by 21 CFR 312 (IND) in the US and by ICH E2A (Clinical Safety) and ICH E2F (DSUR) globally. But in all cases, the relevant regulatory body can carry out inspections of trials as well as marketing authorisation holders (MAHs) to ensure the correct systems are in place to capture and report adverse drug reactions.
Pharmacovigilance Training
Our Good Pharmacovigilance Practice (GPvP) online training platform allows you to access our courses from wherever you are. Get trained and certified at your convenience.
If you are involved in any aspect of pharmacovigilance (GPvP), our four course modules will help you comply with European, Indian & US law. The modules are perfect for you if you are involved in drug safety, pharmacovigilance, regulatory and quality compliance.
Eligibility-
- B.Pharm/ M.Pharm/ Pharm.D
- M.Sc. Life Sciences
- BAMS, BHMS, BDS, MBBS etc
This course covers a variety of important aspects of the career, including reporting, report writing, signal detection and risk management, as well as providing a thorough understanding of the regulatory bodies around the world.
For anyone looking to find a job in pharmacovigilance or drug safety, previous experience in the industry is of great value. Alternatively, a clinical background and first-hand experience with adverse reactions can be advantageous so nurses and pharmacists can also be attractive candidates.
A career in drug safety and pharmacovigilance will generally start with a position as a drug safety associate, officer, scientist or coordinator. Responsibilities will then progress to senior specialist or management roles, often with an in-depth knowledge of a specialty area, such as medical writing, auditing, medical affairs or quality assurance.
Finding a pharmacovigilance job or drug safety position abroad can also be a great opportunity for those seeking a career in this sector and opportunities are prevalent, although generally in the larger companies.
Remuneration for a position in drug safety and pharmacovigilance can vary greatly, with factors including the company, the location, the candidate’s experience and the requirements of the role.
What jobs are available in drug safety and pharmacovigilance?
Jobs in drug safety and pharmacovigilance exist in both permanent and contract arrangements. Temporary agreements can last from three to 12 months, with many of these positions being for drug safety medical writers or interim pharmacovigilance physicians.
- Drug safety associates and officers monitor and track adverse events and reactions, as well as other medically related product information.
- Senior pharmacovigilance consultants process adverse event reports sourced from various studies. The information that is gathered is then submitted to the regulatory authorities.
- Drug safety managers and directors organise the processing and reporting on drug safety reports and review trial-related documents in order to monitor the drug safety profile of specific products. Responsible for medical case reviews and assessing product safety in clinical trials, drug safety physicians work to assess and obtain information about the safety of products.
Pharmacovigilance Course Details
Who can learn?
- Life sciences (M.Pharm., B.Pharm., M.Sc.)
- MBBS, BDS, BHMS, and BAMS
Courses Outline:
- Pharmacovigilance
- Introduction
- Historical Overview
- Basic principles of Pharmacovigilance in Clinical Trials
- Methodologies for Pharmacovigilance
- Pharmacovigilance Regulations in Clinical Research
- FDA and EU perspectives
- Drug regulatory activities MedDRA
- Regulatory aspects in Pharmacovigilance
- Eudra Vigilance
- Pharmacovigilance Regulations in clinical research
- Adverse Drug Reactions and Safety Reporting with Safety Database Training
- ADR Reporting – an introduction
- Causality Assessment of suspected Adverse Drug Reactions
- Periodic Safety Update Reports (PSUR) for Marketed Drugs (ICH E2C)
- Expedited Reporting Requirements
- Individual case safety reports
- Electronic safety update reports
- WHO & safety monitoring
- Case Processing and Narrative writing
- Data Entry
- MedDRA/ WHO-DRL/DD Coding of reported primary diagnosis & Concomitant medications
- Case Narrative Writing
- Query generation and forwarding of queries
- Quality control- an overview
- Active Case / Query follow up – an overview
- Compliance to Clinical Safety and Pharmacovigilance Regulations
- Review of benefits-risk assessments and management
- Scope of Pharmacovigilance inspection and conduct of inspection
- Internal audit of Pharmacovigilance activities of a company
- Pharmacovigilance inspection reports
- Pharmacovigilance compliance and inspection
- Quality System in Pharmacovigilance: Good Practices, SOPs, Preparation for Audits & Inspections
- Scope of Pharmacovigilance inspection and Conduct
- Internal audit of Pharmacovigilance activities of a company
- Key functionalities of the Adverse Event Systems
- Pharmacovigilance Management and Importance
- Pharmacovigilance Databases
- Setting up a Pharmacovigilance center in industry
- Management of Pharmacovigilance Data
- Risk management in Pharmacovigilance
- Data Management & Software solutions
- Effective communication inPharmacovigilance
- Pharmacovigilance in special situations
- Pharmacovigilance capacity building
