For the past 25 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 current 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.
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 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 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.
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