Pharmacovigilance Associate

5 months ago


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 training documents (i.e., SOPs) for the targeted audience (as needed)
- Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)
- Acts as single point of contact with key stakeholders for safety related activities, identifies potential business gaps and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Drug Safety management

Pay: ₹15,033.98 - ₹38,155.36 per month

**Benefits**:

- Internet reimbursement

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus



  • Andheri, Mumbai, 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...


  • 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...


  • Mumbai, Maharashtra, India Vertex Business Solutions Full time

    **Job description** **Responsibilities**: - Receive, review, and process adverse event reports and other safety information in accordance with established procedures and timelines. - Perform case assessment and documentation, including the identification of potential safety concerns and relevant medical information. - Ensure the quality and integrity of...


  • 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. -...


  • 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...


  • 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 Statistical Insights Full time

    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 training documents (i.e.,...


  • Nashik, Maharashtra, India Fusion Technology Solutions Full time

    **Key Responsibilities**: - **Case Management**: - Receive, document, and assess adverse event reports from various sources, including healthcare professionals, consumers, and regulatory authorities. - Ensure accurate and timely data entry of adverse event information into the safety database. - Conduct thorough case investigations and follow-up activities...


  • Balaji Nagar, Pune, Maharashtra, India Vertex Business Solutions Full time

    A Pharmacovigilance Associate plays a crucial role in ensuring adherence to relevant regulations and standard operating procedures. They oversee processes to ensure the effectiveness of drugs while minimizing adverse effects in both research trials and hospital settings. **Responsibilities**: - recording and reporting adverse reactions received from...

  • Pharmacovigilance

    5 months ago


    Mumbai, India recruitments services Full time

    **Pharmacovigilance** jobs involve monitoring, and assessing the risks and benefits of medicines to patients, so it's vital for anyone working in this profession that the information they work on is accurate. **A Medical Coder **transcribes patients records into an insurance-accepted coding system. With this information, they are able to process claims for...


  • Baner, Pune, 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...

  • Drug Safety Associate

    2 months ago


    Mumbai, Maharashtra, India Vertex Solutions Pvt Ltd Full time

    We are seeking enthusiastic and detail-oriented freshers for the position of Drug Safety Associate. As a key member of our pharmacovigilance team, you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products. This entry-level position is an excellent opportunity for recent graduates to start their careers in the pharmaceutical...


  • Mumbai, India 1925 GlaxoSmithKline LLC Full time

    We’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright,...

  • Drug Safety Associate

    1 month ago


    Nagpur, Maharashtra, India Fusion Business Solutions Pvt. Ltd. Full time

    As a Drug Safety Associate, you will play a vital role in ensuring the safety of pharmaceutical products by monitoring, analyzing, and reporting adverse drug reactions (ADRs). This entry-level position is ideal for freshers looking to start a career in Pharmacovigilance and Drug Safety. **Key Responsibilities**: - Monitor and report adverse drug reactions...

  • Drug Safety Associate

    5 months ago


    Kharadi, Pune, Maharashtra, India Vertex Solutions Pvt Ltd Full time

    The primary duty of a Drug Safety Associate involves the ongoing monitoring and evaluation of adverse effects and safety concerns associated with drugs and medical products following market approval. As a Drug Safety Associate, your responsibilities will include monitoring, assessing, and reporting adverse events related to pharmaceutical products. You will...

  • Drug Safety Associate

    5 months ago


    Pune, Maharashtra, India Vertex Pharmaceuticals Full time

    We're seeking dedicated individuals to join our Drug Safety team as Entry-Level Drug Safety Associates. This role offers an exciting opportunity for recent graduates to kickstart their careers in pharmacovigilance and drug safety. **Responsibilities**: - Assist in collecting, processing, and evaluating adverse event reports and safety data. - Ensure...


  • Mumbai, Maharashtra, India IQVIA Full time

    Job DescriptionAs a RA Data Management Associate at IQVIA, you will play a crucial role in ensuring the accuracy and quality of data entered into the XeVMPD system. This involves entering and updating information about medicinal products in accordance with EU regulatory guidelines.Data Management ResponsibilitiesEnter and update information about medicinal...


  • Pune, Maharashtra, India PrimeVigilance Full time

    **Company Description** We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...

  • Drug Safety Associate

    5 months ago


    Nashik, Maharashtra, India Fusion Market Research Full time

    To write an effective drug safety associate job description, begin by listing detailed duties, responsibilities and expectations. We have included drug safety associate job description templates that you can modify and use. Sample responsibilities for this position include: Identify out of scope activities in conjunction with the MSS Functional...