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IDMP Specialist @ Freyr

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 IDMP Specialist

Job Description

Education : UG / PG in Pharma / Life Sciences
Required Skill Set : Regulatory Publishing, IDMP., GxP guidelines, xEVMPD & IDMP knowledge, Veeva Vault
Job Description:
  1. Good understanding about ISO IDMP standards, EMA SPOR Data and IDMP requirements.
  2. Good knowledge on , xEVMPD controlled vocabularies, Data Entry Tool (EVWEB) user manual, EMA registration process, MedDRA coding, EMA account management portal, Organisations management services (OMS) and SPOR master data.
  3. Knowledge on IDMP standards for the interpretation of entire product lifecycle: products in development, investigational products, products under evaluation and authorized products.
  4. Ensured accurate data cleansing and enrichment for CPs in PMS PUI, handled OMS,RMS and SMS requests within the SPOR database and performed data cleanup activities related to ISO IDMP and SPOR.

Job Classification

Industry: Analytics / KPO / Research
Functional Area / Department: Research & Development
Role Category: Pharmaceutical & Biotechnology
Role: Research Associate / Engineer
Employement Type: Full time

Contact Details:

Company: Freyr
Location(s): Hyderabad

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Keyskills:   Regulatory Publishing data cleansing MedDRA coding EMA account management life sciences IDMP GxP

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Freyr

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics) in their entire Regulatory val...