Pharmacovigilance Safety Scientist

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Job Summary

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