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SPVG Scientific Spec I - xEVMPD

2.00 to 5.00 Years   Gurugram   05 Feb, 2022
Seneos Health
Job LocationGurugram
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaOccupational Health / Safety
EmploymentTypeFull-time

Job Description

    Assists with safety and pharmacovigilance activities including (but not limited to) literature screening and review, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, case processing or review of individual case safety reports, authoring or review of aggregate reports and ongoing safety evaluation activities. The processing of information may include filtering, cleaning, migrating, analysing, reporting, filing or publication of data and information. Maintains safety tracking for assigned activities Fosters constructive and professional working relationships with all project team members, internal and external Participates in audits as required/appropriate Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities Files documents according to project specific requirements (electronically or in hard copy as applicable) Provides support with miscellaneous project tasks related to safety and pharmacovigilance activities Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Program Specific FIle or Pharmacovigilance System Master File for post-marketing programs as appropriate Maintains an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, the drug development process and GVP, *Qualification: M. Pharmacy, life science equivalent degree
    • Minimum 2 years of experience in handling xEVMPD data
    • Population or review of xEVMPD data in product database from SmPC and other source documents (PIL/MA letter) including MedDRA and drug coding
    • Experience of working on product database like RIMS, xEVMPD / Article 57 database
    • In-depth knowledge of xEVMPD guidelines (e.g. Art57 Chapter 3.2, splitting of full presentation name, substance name best practice etc.)
    • Database to be used - Art57 (EVWeb), any other database related to xEVMPD record submissions
    • Review of xEVMPD records already submitted by MAH:
    • Validation (review or quality control) of the information available in the xEVMPD record against the source document (e.g. SmPC, PIL, MA approval letter) attached by the MAH to product records
    • Correction of product record data based on validation findings including MedDRA coding of indications
    • Coding of product indications using latest version of MedDRA.
    • Analyse and respond to queries related to xEVMPD data

Keyskills :
standard operating proceduresclinical trialscase processingaudio masteringdrug developmentwork instructionsregulatory intelligence

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