PV - Aggregate Report Writer

Full time Office based

Location: Hyderabad

Job Summary

The Senior Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed. The Senior Pharmacovigilance Safety Scientist, Benefit Risk is expected to be skilled and diligent and liaise with the director and management group members within the team on any issues, as well as coordinate the work with the senior PV Scientists. The Senior Pharmacovigilance Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company.

Essential functions

- Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities.
- Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
- Authoring of Signal Management Reports.
- Performing literature search and validity check for the aggregate reports.
- Reconciliation of relevant process trackers.
- Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
- Generation of Line Listings (LL) from safety database
- Providing reliable support for high priority Ad-hoc activities.

Necessary Skills and abilities

- Analytical and problem-solving skills.
- Sound organizational skills
- Able to work within a team in an open and professional manner
- Excellent attention to detail and focus on quality
- Understanding of ICH-GCP,



FDA, EMA and other revelent Global regulations related to PV
- Demonstrable ability to analyze and quantify large volumes of data in a concise and scientific manner, in keeping with regulatory deadlines.
- Awareness of global culture and willingness to work in a matrix environment
- Knowledge in other pharmacovigilance processes, ability to author/update SOPs or WIs, to identify and author deviations/CAPAs.
- Computer proficiency, IT skills, expertise and an ability to work with web based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)

Educational requirements

- Bachelor/master s degree in pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience

Experience Requirements

- 6+ years experience in Pharmacovigilance with a focus on medical writing and/or literature search and/or signal detection
- Experiences in contributing to the compilation of metrics and participating in discussions about quality internally and with Clients
- Experience in literature screening activities and/or experiences in authoring and reviewing aggregate reports

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 PV - Aggregate Report Writer (Telangana)
🏢 Propharma Group
📍 Telangana