Key Accountabilities
*Note: The below statements describe the general nature and level of the work being performed and are*
*not an exhaustive list of all responsibilities required for the position. Responsibilities vary as applicable.*
Safety Medical Writing and Safety Analysis
Aggregate Safety Reports & Documentation:
- Leads or contributes independently, with supervision, to the preparation and compilation of both scheduled and ad-hoc aggregate safety reports, including Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs) Development Safety Update Reports (DSURs) Periodic Adverse Drug Experience Reports (PADERs), Semi-Annual Safety Reports (SASRs), Annual Risk- Benefit Evaluation (ARBE) report Safety statements, following established templates and guidance.
- Responsible for independently leading straightforward reports and supporting the development of medium complexity reports under guidance.
- Incorporates team review feedback into document drafts,



ensuring all relevant input is addressed and conducting quality reviews to verify consistency and data integrity across safety reports.
- Coordinates the submission process for safety documents to regulatory authorities across multiple regions.
- Generates supporting documentation including comparison documents between local and global labeling, INN checking, and appendices.

Safety Analysis & Signal Management:
- Independently performs signal detection activities by collecting and analyzing data from various sources (databases, clinical, literature, regulatory websites) in accordance with applicable procedural documents.
- Performs both quantitative and qualitative analyses of safety data using established methodologies to identify potential safety signals.
- Manages signal tracking activities and maintains comprehensive signal logs with minimal supervision.
- Supports safety activities for simple molecules with established profiles, contributing to

📌 Medical Writer- I, Patient Safety (Hyderabad)
🏢 Parexel
📍 Hyderabad