Sme-pharmacovigilance

2 days ago


Mumbai Maharashtra, India Cognizant Full time

**Job Summary**

**Responsibilities**
- Triage & intake of ICSRs in ARGUS databases within agreed timelines
- Download and monitor valid ICSRs from Eudra Vigilance (EV)
- or any other sources
- Process literature, spontaneous, clinical trial, and solicited cases
- Search for valid ICSRs in Literature search tools
- Generate reports and submit to health authorities and business partners
- Enter serious and non-serious ICSRs in ARGUS per client SOP and WI with high accuracy
- Code events, indications, patient history using MedDRA
- Code suspect products, amend narratives, and label events
- Obtain follow-up information for all cases per applicable guidelines
- Submit processed cases to regulatory authorities and distribute reports to Partners
- Communicate effectively with client stakeholders and internal teams
- Attend all internal and client trainings to ensure guideline compliance
- Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations.
- Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution.
- Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations.
- Utilize technical skills to troubleshoot and resolve process-related issues, minimizing disruptions and ensuring smooth operations.
- Engage in rotational shifts to provide consistent support and coverage across different time zones.

**Requirements**:

- Bachelor’s / Master’s degree in pharmacy.
- Minimum 3 years relevant work experience in case processing activities.
- Experience in Cardiovascular (CVS), Neuroscience (CNS), Oncology, Immunology therapeutic areas and Gene Therapy will be an added advantage. Experience with global pharma sponsor will be preferred.
- In-depth knowledge and understanding of applicable global, regional, and local regulatory requirements, including Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, SOPs.
- Excellent organizational and time management skills.
- Good knowledge of medical terminology.


  • TL-Pharmacovigilance

    2 weeks ago


    Mumbai, Maharashtra, India Cognizant Full time US$ 9,00,000 - US$ 12,00,000 per year

    Job SummaryWe are seeking an experienced professional for the role of TL-Pharmacovigilance with 6 to 9 years of experience. The ideal candidate will have expertise in Pharma Research & Development and proficiency in MS Excel. Experience in PV Case Processing and Pharmacovigilance & Safety Ops is advantageous. The role involves working in a hybrid model with...

  • TL-Pharmacovigilance

    11 hours ago


    Mumbai, India Cognizant Full time

    Job Summary We are seeking an experienced professional for the role of TL-Pharmacovigilance with 6 to 9 years of experience. The ideal candidate will have expertise in Pharma Research & Development and proficiency in MS Excel. Experience in PV Case Processing and Pharmacovigilance & Safety Ops is advantageous. The role involves working in a hybrid model with...


  • Nashik, Maharashtra, India Clariwell Global Services Full time

    A pharmacovigilance associate ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision. - Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and...


  • Pune, Maharashtra, India Cliniweb Services Full time

    A pharmacovigilance associate ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision. - Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and...


  • Andheri West, Mumbai, Maharashtra, India Vertex Business Solutions Full time

    > A Pharmacovigilance Associate plays a crucial role in ensuring adherence to relevant regulations and standard operating procedures. Specializing in drug safety management, clinical trials, and medical supervision, their primary responsibilities include monitoring and reporting pharmacovigilance developments. They oversee processes to ensure the...


  • Pune, Maharashtra, India Statistical Pharma Full time

    **Primary Responsibilities**: 1. General Responsibilities and Regulatory Compliance: - Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File). - Monitor national pharmacovigilance legislation. -...


  • Karve Road, Pune, Maharashtra, India Statistical Pharma Full time

    1. General Responsibilities and Regulatory Compliance: - Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File). - Monitor national pharmacovigilance legislation. - Ensure appropriate interpretation...


  • Narkhed, Maharashtra, India Cipla Pharmaceutical Limited., Kurkumbh, Pune Full time US$ 90,000 - US$ 1,20,000 per year

    Company DescriptionCipla Pharmaceutical Limited., Kurkumbh, Pune, is a biotechnology company based in Pune, Maharashtra, India. The company is located in Flat No 10, Sanskruti Apt, Near Gokul Hotel, Dound. Cipla is dedicated to developing and manufacturing high-quality pharmaceuticals that contribute to a better quality of life for patients. Cipla is...


  • Mumbai, Maharashtra, India Statistical Pharma Full time

    **Job description** - Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable) - Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners - Supports PV Clinical Specialists in tasks and projects as needed - Responsible for identifying and developing...


  • Mumbai, Maharashtra, India beBeePharmacovigilance Full time ₹ 15,00,000 - ₹ 28,00,000

    Job DescriptionThe Pharmacovigilance Professional is responsible for the collection, management, and analysis of adverse event reports from various sources. They will also contribute to the development and implementation of new safety-related systems, processes, and procedures.Key responsibilities include analyzing complex data, ensuring compliance with...