Pharmacovigilance Associate

1 week 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 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...


  • 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...


  • 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...


  • Mumbai, India Abbott Laboratories Full time

    **MAIN PURPOSE OF ROLE** - Individual contributor that works under limited supervision. **MAIN RESPONSIBILITIES** - Responsible for the company's drug surveillance program including the necessary follow-up, assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. - Participates...


  • Navi Mumbai, India Labcorp Full time

    Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures  Ensure compliance of operations with governing regulatory requirements  Create, maintain and assume accountability for a culture of high customer service Segregate cases received as per priority and due...


  • Mumbai, India Abbott Laboratories Full time

    **Roles and Responsibilities in detail** **Area Business Planning**: - Plan for monthly and quarterly business. - Plan for Trade activation business and over all sales - Plan demand generation and fulfillment - Monitor actual Sales and mid course corrections and inputs to reduce variance against expectations - Prescription audit for Abbott brands and other...


  • Mumbai, India Novartis Full time

    105,000 people reimagining medicine for more than 766 million people globally. To provide country clinical strategic guidance and feasibility assessment for GDD trials. - Your responsibilities include, but are not limited to- To provide clinical strategic and tactical leadership in the country to support GDD trials, clinical development plans which change...