Case Medical Safety Expert - Remote, India - IQVIA

IQVIA
IQVIA
Verified Company
Remote, India

1 month ago

Deepika Kaur

Posted by:

Deepika Kaur

beBee Recuiter
Description

Major duties and responsibilities:
- oversees the Medical Review (MR) of ICSRs as per predefined activity and job-role in PV safety database, with special focus on case medical accuracy and documentation, - maintains overall accountability for the timeliness and quality of medical case management activities outsourced to service providers, - leads or participates in cross-functional projects or initiatives within Global Pharmacovigilance collaborates with the GSO in the review of Clinical trial and post-marketing program documentation and on labeling activities, - establishes strong collaboration with cross-functional groups within and outside the company (i.e Business Partners, CRO), - is the SME during internal / partner audits and inspections


Skills and Education:

  • MD or Physician
  • 3 to 5 years of experience in healthcarerelated field and/or patientcare activities desirable
  • 3+ years of Pharmacovigilance experience or equivalent relevant pharmaceutical industry experience (clinical development, data management, etc.)
  • Supervisory and mentoring experience highly desirable
  • Thorough medical knowledge of the safety profile of assigned products
  • Experience in pharmacovigilance databases
  • Robust expertise with MedDRA coding
  • Thorough knowledge of regulations (e.g. FDA, EMA )
  • Computer literacy, especially MS Office programs
  • Able to communicate, verbally and in writing in a good and understandable English level
  • Able to influence and establish strong collaborations with crossfunctional groups within and outside the company
  • Able to prioritize activities and demonstrate high quality of work, flexibility
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