Pharmacovigilance Associate

6 months ago


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 and implementation of national pharmacovigilance regulation for both

drugs and devices.
- Responsible for liaising with the Ministry of Health (MoH)/national regulatory authority (RA), work with legal, quality, medical and regulatory on safety issues if necessary.
- Responsible for appropriate communication between product safety locally, Global Patient Safety (GPS), and other relevant stakeholders (product complaints, medical and regulatory affairs).
- Has awareness and provides input to local Risk Management Plans, local risk minimization activities and local Post Safety Authorization Studies as applicable.
- Ensure local business alliance and third-party safety agreements are in place, up to date and followed as required.
- Provide local training (initial and/or refresher) for employees and/or business alliance partners to raise the awareness of PhV, as required.

**Salary**: ₹295,418.58 - ₹1,457,420.46 per year

**Benefits**:

- Health insurance
- Provident Fund
- Work from home

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...


  • 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. -...


  • Pune, 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...


  • Pune, 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. -...


  • 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...


  • Wakad, Pune, Maharashtra, India TechnoBridge Systems Pvt Ltd Full time

    **Responsibilities**: - Monitor and report adverse drug reactions (ADRs). - Prepare safety reports and ensure regulatory compliance. - Collaborate with healthcare professionals on drug safety. **Qualifications**: - Degree in Pharmacy, Life Sciences, or related field. - Knowledge of pharmacovigilance and medical terminology. - Strong analytical and...


  • 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...


  • 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...


  • 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...


  • Pune, Maharashtra, India Lifelancer Full time

    About the RoleAt Lifelancer, we are committed to connecting talented individuals with opportunities in life sciences, pharma, and IT. We are seeking a dedicated Pharmacovigilance Specialist to join our team as a fresher-level associate. This role is ideal for individuals with 0 to 1 year of work experience and is available in multiple locations including...


  • 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 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.,...


  • Pune, Maharashtra, India TransPerfect Full time

    We are seeking a highly organized and detail-oriented Program Management Associate to join our Pharmacovigilance Solutions team at TransPerfect. This role will be responsible for the day-to-day administrative tasks related to literature monitoring projects, focusing on support functions for the wider Production team.ResponsibilitiesThe successful candidate...


  • Pune, Maharashtra, India EVERSANA Full time

    We are seeking a highly skilled Global Pharmacovigilance Expert to join our team at EVERSANA. In this role, you will play a critical part in ensuring the safety of pharmaceutical products and protecting public health.About EVERSANA:EVERSANA is a global leader in life sciences services, committed to creating a healthier world through innovative...

  • Drug Safety Associate

    6 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

    6 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...


  • 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...