When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 easy 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 Manageme

📌 Medical Writer- I, Patient Safety (Hyderabad)
🏢 1060 Parexel International
📍 Hyderabad