Pharmacovigilance Scientist

About thejob

For the past 20 yearsProPharma has improved the health and wellness of patients byproviding advice and expertise that empowers biotech med device andpharmaceutical organizations of all sizes to confidently advancescientific breakthroughs and introduce new therapies. As the worldslargest RCO (Research Consulting Organization) ProPharma partnerswith its clients through an advisebuildoperate model across thecomplete product lifecycle. With deep domain expertise inregulatory sciences clinical research solutions quality compliancepharmacovigilance medical information and RD technology ProPharmaoffers an endtoend suite of fully customizable consulting solutionsthat derisk and accelerate our partners most highprofile drug anddevice programs.

JobSummary

Monitoring of incomingreports from various sources including mailboxes EudraVigilance andliterature search results.

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

Triage of incoming reports for completeness duplicate checkslegibility and validity.

Perform literaturesearches according to the searchstrategy.

Responsible for case processing orquality review of coding all medical history events drugs/procedures/indication and laboratory tests according to theappropriate dictionary such as MedDRA Company Product DictionaryWHODD

Responsible for writing or reviewingmedically relevant safety narratives of cases and checking thecompleteness and accuracy of the data entered in the variousfields.

Performs clear and accurate data captureof cases following client conventions/guidelines and StandardOperating Procedures (SOPs).

Ensures that theexpectedness causality assessment as well as seriousness criteriaare accurate for the events.

Request followupand perform query management asapplicable.

Maintaining respective trackersrequired for the process and clientdelivery.

Maintaining an awareness of globalregulatory reporting obligations and organizing work to ensurecompliance with internal and regulatory timelines for adverse eventreporting.

Attending internal drug safety andprojectspecific training sessions.

Performstraining assigned on internal and client Learning Management System(LMS) as applicable within designatedtimelines.

Necessary Skills AndAbilities

Excellent verbalwritten and interpersonal communication skills.

Strong organization and prioritization skills; able tomultitask.

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

Understanding of patientsafety regulatory obligations.

Flexibility toadapt and meet fluctuating business priorities.

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

Capability to workcollaboratively as well as efficiently in a teamenvironment

EducationalRequirements

PhDMPharmacy/BPharmacy Doctor of Pharmacy (PharmD) from PCI recognizedUniversity/College.

ExperienceRequirements

Preferred: 23 yearsof experience in ICSR CaseProcessing.

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RemoteWork :

No