Pharmacovigilance Associate

3 days ago

Hyderabad Telangana, India Fusion Business Solutions Pvt. Ltd. Full time

**Job Type**: Full-Time, Entry-Level

**Job Summary**:
We are seeking a highly motivated Pharmacovigilance Associate to join our team. As a fresher in pharmacovigilance, you will be responsible for supporting drug safety efforts by assisting with adverse event reporting, case processing, and safety data analysis.

**Key Responsibilities**:

- Assist in adverse event (AE) reporting and ensure accurate submission of AE data to relevant regulatory authorities.
- Support case processing activities, including data entry, medical coding (MedDRA), and Individual Case Safety Reports (ICSR) preparation.
- Contribute to signal detection activities by identifying trends and patterns in adverse event data.
- Ensure compliance with Good Pharmacovigilance Practices (GVP) and International Conference on Harmonisation (ICH) guidelines.
- Support the creation and maintenance of Periodic Safety Update Reports (PSUR) and other regulatory safety documents.
- Collaborate with cross-functional teams to ensure timely and accurate reporting of safety data.
- Assist with the management and analysis of safety data from clinical trials and post-marketing surveillance.
- Review and maintain pharmacovigilance databases and ensure the quality and integrity of safety data.
- Stay up-to-date with global pharmacovigilance regulations and safety monitoring practices.

**Key Skills and Qualifications**:

- Bachelor’s degree in Pharmacy (B.Pharm) or related field. Postgraduate certifications in Clinical Research/Pharmacovigilance (preferred).
- Familiarity with drug safety concepts, adverse event reporting, and regulatory guidelines.
- Ability to write clear and concise safety reports and communicate effectively with cross-functional teams.
- Awareness of ICH guidelines, FDA, EMA regulations, and GVP principles is desirable.

Pay: ₹219,096.37 - ₹1,185,246.02 per year

Schedule:

- Day shift

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

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