Key Responsibilities:
Authoring and Reviewing PSURs and RMPs
Prepare and review Periodic Safety Update Reports (PSURs/PBRERs) and Risk Management Plans (RMPs) for submission to health authorities.
Ensure the accuracy, completeness, and regulatory compliance of all PSURs and RMPs.
Literature Search and Validation
Perform literature searches to gather relevant data for PSUR and RMP 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:
Bachelor's 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.
Strong organizational skills with the ability to manage multiple tasks and projects simultaneously.
Demonstrated ability to collaborate effectively with cross-functional teams and provide expert
