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 PSUR preparation and review

- Authoring and Reviewing PSURs:
- Prepare and review Periodic Safety Update Reports (PSURs/PBRERs) for submission to health authorities.
- Ensure the accuracy, completeness, and regulatory compliance of all PSURs.

- Literature Search and Validation:
- Perform literature searches to gather relevant data for PSUR preparation.
- Validate the information obtained from literature searches to ensure accuracy.

- Data Management:
- Extract and validate data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP).
- Generate Line Listings (LL) from the safety database for inclusion in PSURs.

- Process Management:
- Manage and reconcile relevant process trackers to ensure all activities are documented and on schedule.
- Provide reliable support for high-priority ad-hoc activities related to PSUR preparation.

- Client Interaction:
- Communicate with client personnel to resolve issues related to PSURs,



ensuring adherence to client policies.
- Ensure that PSUR deliverables comply with regulatory requirements and are submitted within agreed timelines.
- Subject Matter Expertise and Training:
- Serve as a subject matter expert (SME) for PSUR preparation and review.
- Provide training and mentoring to team members on PSUR-related processes and regulatory requirements.

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 PSUR preparation and review.
- Knowledge of regulatory requirements for PSURs/PBRERs.
- Strong analytical and problem-solving skills with the ability to evaluate and interpret complex safety data.
- Excellent written and verbal communication skills.
- Proficiency in safety databases and data extraction/validation processes.
- Solid organizational skills with the ability to manage multiple tasks and projects simultaneously.
- Demonstrated ability to collaborate effectively with cross-functional teams and provide expert

📌 PSUR Report Authoring and Quality Review (Hyderabad)
🏢 Vizen Life Sciences
📍 Hyderabad