Pharmacovigilance Safety Scientist

Job Summary

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 relevant 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."
• 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)
  

Educational Requirements

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

Experience Requirements

• 2+ 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