Pharmacovigilance Safety Scientist, Benefit Risk - Hyderabad

Job summary

The Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed.

Responsibilities

• 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.

Qualifications

• 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

Skills

• 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.

Benefits

• Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines.
• Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
• 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)

Job description