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🧠 Steps in ICSR (Individual Case Safety Report) – A Complete Journey of Ensuring Patient Safety

🧠 Steps in ICSR (Individual Case Safety Report) – A Complete Journey of Ensuring Patient Safety

 In Pharmacovigilance, every Individual Case Safety Report (ICSR) tells an important story. It reflects how a medicine interacts with a patient in real life. ICSRs help regulatory authorities and drug safety teams identify, analyze, and prevent adverse drug reactions , ensuring safer healthcare outcomes. Below is the complete life cycle of an ICSR , from the moment an adverse event is reported to its regulatory submission. 🧾 1. Case Intake / Receipt The ICSR process starts when a potential Adverse Event (AE) is reported. Reports may come from: Healthcare professionals Patients or caregivers Literature articles Clinical trials Regulatory agencies To consider the report valid , it must meet four essential criteria: Identifiable patient Identifiable reporter A suspect drug/procedure A reported adverse event 💻 2. Data Entry All information collected is entered into a Safety Database (e.g., Argus, ARISg, Veeva). This includes: Patient det...

We’re Hiring! Build Your Career in Primary Research at Sciatius Research

We’re Hiring! Join Our Growing Team at Sciatius Research Work Mode: Remote (Rotational shift)  |  Experience: Fresher  |  Function: Primary Research Are you passionate about research , client interaction , and problem-solving ? We’re expanding our team and looking for talented professionals to join us at Sciatius Research . Open Roles Analysts Senior Research Analysts Managers Associate Managers (Primary Research) What We’re Looking For Excellent written and verbal communication skills Natural curiosity and structured thinking Ability to conduct primary research and synthesize insights Client-first mindset and proactive problem-solving Why Join Sciatius Research? Work with global clients across industries Collaborative, learning-driven culture Fast growth with clear career paths in primary research Remote-first with rotational shifts for global coverage Role Details Location: Remote Work Mode: Rota...

Clinical Research Associate (CRA) Jobs – CBCC Global Research | Delhi, Bengaluru, Pune, Kolkata

CBCC Global Research is hiring experienced and enthusiastic Clinical Research Associates (CRAs) to support innovative oncology and non-oncology clinical studies across India. Locations Delhi • Bengaluru • Pune • Kolkata What You’ll Bring 1–4 years of on-site monitoring experience in clinical trials Strong understanding of GCP , ICH guidelines , and regulatory processes Excellent communication and organizational skills Willingness to travel for site monitoring visits Why Join CBCC Global Research Work on cutting-edge oncology and non-oncology studies Collaborative, growth-oriented environment Competitive compensation with strong learning opportunities How to Apply Send your updated CV to sonu.gupta@cbcc.global with the subject line: Application – CRA – [Your Name] – [Preferred City] About CBCC Global Research CBCC Global Research partners with leading investigators and institutions to deliver high-quality clinical research with patient-centric...

Dabur India Limited Hiring Placement Coordinators | Pharmacy & MBA Colleges

  Dabur India Limited Hiring Placement Coordinators Dabur India Limited is reaching out to Pharmacy and MBA colleges to collaborate with dedicated Placement Coordinators across multiple locations. This opportunity is aimed at strengthening campus recruitment connections and creating meaningful career opportunities for students. Locations We Are Targeting Hyderabad Bangalore Chennai Vijayawada Karimnagar Who Should Connect? This collaboration invitation is ideal for: Placement Coordinators in Pharmacy colleges Placement Coordinators in MBA / Management colleges Institutions looking to build strong industry partnerships Why Collaborate with Dabur? Strong industry presence and corporate legacy Opportunities for student placements and internships Focus on building long-term campus recruitment associations Exposure to real industry hiring needs and trends About Dabur India Limited Dabur is one of India's most trusted FMCG and Ayurvedic healthcare brands, k...

Wipro Hiring: Case Processing Associates (Pharmacovigilance)

  Wipro Hiring: Case Processing Associates (Pharmacovigilance) – Pune Wipro is Hiring: Case Processing Associates (Pharmacovigilance) – Pune Wipro is inviting applications from Pharmacy, Nursing, and Life Science graduates for Case Processing Associate roles in Pharmacovigilance (PV) . Role Highlights Job Title: Case Processing Associate (Pharmacovigilance) Location: Pune Work Mode: Onsite (Work From Office) Shifts: General / Rotational Eligibility: B.Pharm / Nursing / BDS / BMS / Life Sciences Experience: Freshers to 4 years Who Can Apply This role is ideal for candidates who: Hold a degree in B.Pharm, Nursing, BDS, BMS, or Life Sciences Are freshers or have up to 4 years of relevant experience Are comfortable with onsite work and general/rotational shifts  Key Responsibilities (Typical for PV Case Processing) Collect, review, and process individual case safety reports (ICSRs) Ensure completeness, accuracy, a...

✨ Job Opportunity at Aculife Healthcare Pvt. Ltd (Nirma Group) – Regulatory Affairs | Ahmedabad

 Aculife Healthcare Pvt. Ltd, part of the well-known Nirma Group , is hiring for the Regulatory Affairs (RA) team at its Head Office in Ahmedabad . This role is ideal for candidates with experience in LATAM (Brazil, Mexico) submissions and exposure to EU submission systems . 📍 Job Location Ahmedabad, Gujarat (Corporate Office) 📝 Key Job Responsibilities Compile & review registration dossiers as per country-specific regulatory guidelines. Work with LATAM regulatory filings (Brazil, Mexico) and EU submission platforms . Review key technical documentation , including: DMF Product Development Report BMR / BPR Analytical Method Validation Report Specification (STP) Stability Study Report BE Study Report Prepare & compile deficiency responses for new product submissions and backlog dossiers. Review and submit post-approval variations per updated guidelines. Communicate with international regulatory teams/agents/distributors for timel...

Top Pharmacovigilance Interview Questions and Answers (Fresher to Experience)

Title: Pharmacovigilance Interview Questions and Answers Define Pharmacovigilance Pharmacovigilance is the science of collecting, monitoring, researching, evaluating, and interpreting data from healthcare professionals and patients about the adverse effects of medicines, biological products, herbal treatments, and other medical substances. The purpose is to ensure drug safety and protect public health. What Are the Minimum Criteria Required for a Valid Case? A valid safety case must contain: • An identifiable reporter • An identifiable patient • A suspect product • An adverse drug event Define Adverse Drug Event (ADE) An Adverse Drug Event is any undesirable medical occurrence that happens after the administration of a pharmaceutical product, regardless of whether it is related to the drug. Define Adverse Drug Reaction (ADR) An Adverse Drug Reaction is a harmful, unintended response to a drug that occurs at normal doses used for diagnosis, treatment, or prevention of...