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Posted: Saturday, August 30, 2014 12:16 AM

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LEO Pharma - Parsippany, NJ

About the Job

LEO Pharma is an independent, research-based specialty pharmaceutical company committed to the discovery and development of novel drugs for patients within the area of dermatology in the U.​S.​ For 105 years our products, which are marketed in more than 100 countries worldwide, have improved the quality of millions of people's lives around the world.​

We understand that people power our success.​ Our global team – consisting of around 4,800 people in 61 countries worldwide – is LEO Pharma’s greatest asset.​ Thanks to this incredible mix of people from different cultures and backgrounds, LEO Pharma is a workplace where innovation thrives and people grow.​

This is why we continually seek to attract passionate, dedicated and solution-orientated people and ensure that our people develop professionally.​ Our future depends on people who can drive our activities, penetrate new territories, realise potential in existing markets and build an even stronger pipeline.​ If LEO Pharma is to realise its vision, we need people who think innovatively and act with integrity.​

We currently have an opening for a Global Drug Safety Specialist in our Parsippany, NJ headquarters.​ You will be responsible to receive, enter, triage, and process AE/​OE cases to ensure compliance of global regulatory timelines and targets.​

Responsibilities:

Handling of mailbox/​case receipt

To perform case receipt - scan and file source documentation
To check post, faxes and forward/​distribute reports to relevant personnel
To check readability, correctness and completeness of scanned docs
To sort and prioritize the inbox in DRUGDK
To handle customer complaints
To review and handle literature searches
To screen and identify any potential AE/​OEs in relation to customer complaints



Process ICSRs in the safety database

To receive and check completeness of case information and source documents for all case types
To check and follow-up for critical information (eg.​ product, event, reporter, patient)
To perform duplicate checks of cases
To perform case triage
To accurately enter case-data into the database and attach relevant documents to the case
To perform MedDRA and WHO Drug Dictionary coding of all cases
To perform writing of case narratives, establish listedness and causality assessments of both serious and non-serious ICSRs
To communicate with local affiliates, authors of scientific literatures for follow-up information



Follow-up procedure

To generate AE/​OE follow-up correspondence, conduct and log follow-up of cases with reporters to comply with follow-up procedures





Ensure case quality and compliance

To ensure reporting timelines and targets are met
To ensure coding accuracy of cases
To perform quality control of cases
To investigate and log reasons for late reporting
To perform case reconciliation



Submission and distribution of ICSRs

To finalize AE/​OE case documentation and prepare for distribution/​submission
To submit and distribute all AE/​OE cases as per requirement



Other responsibilities

Participate in meetings as required e.​g.​ team/​section/​department meetings
Contribute to the maintenance of SOPs, work instructions and work tools
Keep up to date of changes and developments of PV regulation
Complete all company-based and job-related training as assigned by LEO Pharma within the required timeline.​
Additional duties as assigned by LEO Pharma Management and approved by direct leader





Requirements:

Minimum 2+​ years of experience as a HCP with relevant health science background, e.​g.​ nurse, pharmacist
Bachelor’s degree required.​
Strong computer literacy and knowledge of safety databases
Fundamental understanding of EMA/​ICH/​FDA guidelines
Basic ability to analyze and interpret data
High level of accuracy, integrity and quality in work practices
Good communications skills, oral and written; fluent in spoken and written English
Strong knowledge of medical terminology
Competent knowledge of medical terminology
Good verbal and written English
Strong multitasking, organization, prioritization and ability to think ahead
Good understanding of case processing procedures
Understand AE/​OE document practices and distribution methods (paper based and software)
Basic knowledge of medicine and pathology to apply in case triage and analysis





Would you like to be part of our success in the US?​ Please forward resume, cover letter & salary requirements to: Recruitment.​US@​leo-pharma.​com (Att: GDSS-MB).​

An Equal Opportunity Employer

• Location: New Jersey

• Post ID: 50901328 newyork
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