Pharmacovigilance Associate

6 days ago


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.
- 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**: ₹18,000.00 - ₹45,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Work from home

Schedule:

- Day shift

Supplemental pay types:

- Joining bonus
- Performance bonus



  • Pune, India Crestenroll Technologies Full time

    As a Pharmacovigilance Associate you are part of the Pharmacovigilance Department (sometimes called the Drug Safety Department). Your role is one of reporting adverse effects (AEs) and side effects, in accordance with the current Dutch and European legislation for pharmacovigilance. You may also train colleagues in departments such as marketing and sales,...


  • 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. -...


  • 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 Bitwise Pharma Full time

    Job description - Provide high quality, balanced and timely information to requests for medical information from both internal and external customers. - Maintain a database of Medical Information requests and responses. - Develop and maintain current knowledge of products and disease states. - Maintain references and other Medical Information resources. -...


  • Pune, India Excent Research Pvt. Ltd Full time

    Excent Research is currently seeking to expand its Research and Development team for its Pharma Division. As part of this effort, we are actively recruiting for the positions of Pharmacovigilance Associates and Clinical Researchers. Eligibility: BSc, MSc, B Pharmacy, M Pharmacy, PharmD, Any UG / PG in Life Sciences **Job Types**: Full-time,...


  • Pune, India Statistical Pharma Full time

    Processing adverse events reports from post marketing sources into Teva's global safety database: - The different sources / types of reports includes: Reports from the scientific literature, Teva partners (other pharmaceutical companies), Health Authorities, Non-interventional studies and other programs - The processing includes Adverse Events coding (in...


  • 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...


  • Pune, India Ardent Research Full time

    Provide medical and clinical guidance to managers before, throughout, and following clinical trials. - Maintain consistency of safety assessments. - Perform a variety of safety assessments. - Serve in cross-functional teams as a medical and scientific representative. - Ensure regulatory compliance and safety throughout trial. - Submit periodic reports to the...


  • Pune, Maharashtra, India Cliniweb Services Full time

    Collect, review, and process adverse event reports from clinical trials, post-marketing sources, and literature. - Ensure timely and accurate entry of safety data into safety databases (e.g., Argus, ARISg). - Prepare and submit Individual Case Safety Reports (ICSRs) to regulatory authorities within stipulated timelines. - Conduct follow-ups with healthcare...


  • Pune, India Deloite Software Pvt Ltd Full time

    **Typical Responsibilities Include** - Recording and reporting adverse reactions received from healthcare professionals and consumers - Conducting in-depth interviews with patients and healthcare professionals - Developing a thorough knowledge of products - Completing periodic safety update reports on drugs and other treatments - Writing and reviewing...