Safety and PV Specialist

3 days ago

Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 50,00,000 - ₹ 75,00,000
Job Title: Safety and PV Specialist I (Japanese Language Expert)

We are seeking a skilled professional to fill the position of Safety and PV Specialist I (Japanese Language Expert) in our organization. This role will be responsible for ensuring compliance with Standard Operating Procedures (SOPs) and project/program-specific safety plans, as well as maintaining accurate and up-to-date records.

About the Role:

This position is critical to the success of our team, and we are looking for an individual who can provide high-quality work while working independently and collaboratively with colleagues. The ideal candidate will have excellent interpersonal and communication skills, as well as advanced skills in Microsoft Office applications.

Key Responsibilities:
  • Receive and track ICSRs, process them according to SOPs and project/program-specific safety plans, and evaluate data for completeness, accuracy, and regulatory reportability.
  • Triage ICSRs and identify missing information, raise queries, and follow up until resolution.
  • Enter data into safety databases, code events, medical history, concomitant medications, and tests, and compile complete narrative summaries.
  • Generate timely, consistent, and accurate expedited reports per regulatory requirements and maintain safety tracking for assigned activities.
Required Skills and Qualifications:
  • Master's in Pharmacy or Master's in Science/Healthcare field, or equivalent combination of education and experience.
  • Excellent interpersonal and communication skills, as well as advanced skills in Microsoft Office applications.
Benefits:

This role offers the opportunity to work on challenging projects, develop new skills, and contribute to the success of our team. We offer a competitive salary and benefits package, as well as opportunities for career growth and development.

Others:

We are committed to creating a positive and inclusive work environment, and we welcome applicants from diverse backgrounds. If you are a motivated and detail-oriented individual who is passionate about delivering high-quality work, we encourage you to apply for this exciting opportunity.

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