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Case Processing

Job Description

The PV Case Processor (CP) is responsible for full global data entry of AE/ADR case reports from various sources into the Global Pharmacovigilance database. This includes entry of all relevant case information into structured database fields in accordance with internal case processing standards, the coding data, where applicable, and the preparation of a case narrative.

Completeness, consistency with company standards and timely processing of case reports must be ensured in order to keep compliance with very strict international ADR reporting requirements and timelines.

Major Tasks of Role:

Promptly and accurately identify, interpret and enter adverse event and all relevant corresponding case information into the global database for serious and non-serious AE/ADR case reports. This must be done in accordance with internal data entry standards and within specific timelines as prescribed by global regulations and SOPs.

Verify, as prescribed by regulatory guidelines, that trade names are correctly translated into INN (International Non-proprietary Name).

Perform accurate coding of incoming serious and non-serious adverse events and other case information using MedDRA terminology.

Perform assessment of cases regarding the global listedness
• Create comprehensive case narratives based on all relevant, related information received from local affiliate and/or from various source documents.

Determine drug-event relationship in non-serious ADR/AE case reports.

Request additional follow up information from local affiliate for the completion of case reports.

Contribute to a continuous improvement of PV system and processes.

Value added to the success of the company:

Contribution to the company’s compliance with global pharmacovigilance regulations and ensures timely and high quality input of standardized data into the continuous monitoring of safety profiles and resulting risk management activities of client medicinal products in his therapeutic area, which are key basic requirements to enable the approval and marketing of pharmaceutical products around the world.

Builds and maintains significant product knowledge regarding dozens of different products and clinical projects in the respective therapeutic area Contribution context:

Work relations:

Part of a global matrix of specialist with frequent contacts to functions within and outside the Pharmacovigilance organization. Strong interaction with PV Case Processing Leader and PV Case Evaluators to ensure high medical quality of the ICSRs. Close liaison with pharmacovigilance personnel in in over 60 countries, periodically interacts with internal and external therapeutic teams relevant to the incumbent's assigned therapy area and GPV internal functions (PV Systems, compliance group, QC group, training, and standards)

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Starpoint is an Equal Opportunity Employer.

Job Requirements

Pharmacist, Veterinarian, Biologist, Nurse, HCP Life Science degree, or similar education with medical or scientific focus ideally with previous PV experience.

Fluency in English (verbally and in writing). Must be able to fluently communicate with colleagues from PV data entry sites in other countries.

Should be willing and able to quickly develop in-depth understanding of database field structure, and processing rules.

Should have or quickly develop basic knowledge of ICH principles of SAE/AE reporting along with basic understanding of local and global regulatory rules and regulations and basic knowledge of safety policies and proc edures in the major countries.

Should have or quickly develop good understanding of AE and drug coding conventions (MedDRA, WHO-DD).

Basic knowledge of standard office software packages (Word, Excel)
• High sense of responsibility and accountability and special sense for diligence even for routine processes
• Proactive behavior and ability to keep timelines
• Well established interpersonal skills. Excellent oral and written communication skills are essential
• Must possess good medical/clinical interpretati on skills based on potent ially limited information provided along with a comprehensive understanding of medical terminology.

Should possess well established decision-making and organizational skills, along with practiced training skills.

Job Snapshot

Contact Name Peter Bonjuklian
Post Date 11/30/2014
Location Parsippany, NJ
Base Pay $41.60 /Hour
Employment Type Contractor
Job Type Pharmaceutical
Education Not Specified
Experience Not Specified
Manages Others Not Specified
Relocation No
Industry Pharmaceutical
Required Travel Not Specified
Job ID SASCONS00072593
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