Job highlights

- Qualifications: . Bachelors degree in a relevant scientific or medical field (e.g.,Pharmacology,Medicine,Life Sciences)

- Advanced degree preferred

- Experience in pharmacovigilance,drug safety,or related field,with a focus on safety signal detection and triage

- Experience in managing EudraVigilance database requests and conducting QC checks of database searches

Key Responsibilities:

- Safety Signal Detection and Triage:

- Perform safety signal detection and triage activities for a challenging product portfolio.

- Identify new safety signals based on review and comprehensive medical evaluation of technical hits in post-marketing spontaneous reporting databases, analyzing single case reports as well as aggregate data available.

- Expert Evaluation:

- Provide expert evaluation of results of post-marketing signal detection activities at cross-functional team meetings, including Safety Review Meetings and Joint Safety Committees as appropriate.

- Collaboration:

- Collaborate productively with the safety leads for the respective products.

- Serve as a core member of the cross-functional Signal Management Team, providing expert input for post-marketing signal detection activities using internal and external spontaneous reporting databases.

- Database Searches and Analysis:

- Perform database searches in external Health Authority databases (FAERS, Vigibase, iDAP, DAEN), analyzing and reporting the results.





- Perform QC checks of Health Authority database searches done by colleagues.

- EudraVigilance Management:

- Manage EudraVigilance database requests, including monitoring EudraVigilance for assigned products.

- Provide support in training and mentoring junior Safety Signal Colleagues.

- Development of Guidance Documents:

- Drive the development and update of Business Guidance documents and SOPs.

- Contribute to the development of new approaches for automated signal detection in internal/external databases

Qualifications:

- Bachelors degree in a relevant scientific or medical field (e.g., Pharmacology, Medicine, Life Sciences). Advanced degree preferred.

- Experience in pharmacovigilance, drug safety, or related field, with a focus on safety signal detection and triage.

- Knowledge of post-marketing spontaneous reporting databases and Health Authority databases (FAERS, Vigibase, iDAP, DAEN).

- Robust analytical and problem-solving skills with the ability to evaluate and interpret complex safety data.

- Demonstrated ability to collaborate effectively with cross-functional teams and provide expert input in a matrix environment.

- Experience in managing EudraVigilance database requests and conducting QC checks of database searches.

- Strong organizational skills with the ability to manage multiple tasks and projects simultaneously.

- Excellent written and verbal communication skills.

- Proficiency in developing and updating SOPs and Business Guidance documents.

📌 Jr Drug Safety Associate II - Signal Management (Hyderabad)
🏢 Vizen Life Sciences
📍 Hyderabad