Principal Scientist

1 week ago


Bengaluru, Karnataka, India ScaleneWorks Full time
Job Title: Principal Scientist - Pharmacovigilance Expert

Key Responsibilities

  • Ensures the accurate and timely evaluation of safety signals for assigned products, providing clear and concise conclusions in regulatory documents.
  • Contributes to the development of Risk Management Plans (RMPs) and Risk Tables for designated products, collaborating with senior personnel.
  • Authors and reviews regulatory periodic reports and associated documentation, adhering to agreed processes and timelines.
  • Prioritizes tasks and manages time effectively to meet multiple deadlines, demonstrating attention to detail and quality.

About the Role

  • Builds and maintains effective working relationships with line functions to address safety issues.
  • Supports safety governance and cross-functional teams to detect and address product safety issues, implementing risk-reduction strategies in clinical study protocols and product labeling.
  • Mentors junior colleagues, contributing to the evaluation of their activities and providing knowledge and skills guidance.

Requirements

  • Health Sciences or Health Care Professional degree required, with advanced degree preferred.
  • 10-13 years of pharmacovigilance experience in Safety Evaluation and Risk Management, encompassing clinical development and post-marketing activities.
  • Knowledge of international pharmacovigilance requirements and drug development processes.

Scope of Accountability

  • Safety signal detection, assessment, and risk management, with potential to chair Safety Review Teams.
  • Provides medical/scientific knowledge in safety evaluation and risk management of Global pharma company products.


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