Pharmacovigilance Scientist

About the job

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. As the worlds largest RCO (Research Consulting Organization) ProPharma partners with its clients through an advisebuildoperate model across the complete product lifecycle. With deep domain expertise in regulatory sciences clinical research solutions quality compliance pharmacovigilance medical information and RD technology ProPharma offers an endtoend suite of fully customizable consulting solutions that derisk and accelerate our partners most highprofile drug and device programs.

Job Summary

Monitoring of incoming reports from various sources including mailboxes EudraVigilance and literature search results.

Downloading of L2A (Regulatory authority) and MLM cases from EV Web regularly by using clientspecific filters for the triage process.

Triage of incoming reports for completeness duplicate checks legibility and validity.

Perform literature searches according to the search strategy.

Responsible for case processing or quality review of coding all medical history events drugs /procedures/indication and laboratory tests according to the appropriate dictionary such as MedDRA Company Product Dictionary WHODD

Responsible for writing or reviewing medically relevant safety narratives of cases and checking the completeness and accuracy of the data entered in the various fields.

Performs clear and accurate data capture of cases following client conventions/guidelines and Standard Operating Procedures (SOPs).

Ensures that the expectedness causality assessment as well as seriousness criteria are accurate for the events.

Request followup and perform query management as applicable.

Maintaining respective trackers required for the process and client delivery.

Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for adverse event reporting.

Attending internal drug safety and projectspecific training sessions.

Performs training assigned on internal and client Learning Management System (LMS) as applicable within designated timelines.

Necessary Skills And Abilities

Excellent verbal written and interpersonal communication skills.

Strong organization and prioritization skills; able to multitask.

Computer proficiency expertise and an ability to deal with webbased applications email and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/PowerPoint).

Understanding of patient safety regulatory obligations.

Flexibility to adapt and meet fluctuating business priorities.

Able to occasionally work extended and/or flexible schedules to meet client requirements.

Capability to work collaboratively as well as efficiently in a team environment

Educational Requirements

PhD MPharmacy/BPharmacy Doctor of Pharmacy (PharmD) from PCI recognized University/College.

Experience Requirements

Preferred: 23 years of experience in ICSR Case Processing.

Please use the below link for job application and quicker response.

Remote Work :

No