Global Pharmacovigilance Specialist

1 day ago


Hyderabad Secunderabad Telangana, India beBeeExpert Full time ₹ 1,04,000 - ₹ 1,30,878
Pharmacovigilance Expert

The role of a Pharmacovigilance Science Expert is crucial in supporting an international team dedicated to safety surveillance throughout the product lifecycle.

This safety expert performs core pharmacovigilance activities, collaborating with Global Safety Leads/Managers to identify, evaluate, and analyze safety data for both marketed products and those in post-marketing and clinical development stages.

Main Responsibilities:

  • Manage ongoing signal detection activities, involving the synthesis of data from multiple sources, including PV databases, literature, and external databases.
  • Coordinate and author health hazard evaluations and safety evaluation reports.
  • Manage entry and tracking of signals, ME, INR in SMART tool and support GSLs/GSMs with any SMART related activities.
  • Review periodic signal detection reports.
  • Contribute to responses to Health Authority questions or inquiries from internal or external stakeholders.
  • Be a core member of the Safety Management Committee, contributing to produce necessary data outputs and preparing slide presentations.
  • Support GSL/GSM to provide safety content for new drug applications and other regulatory filings.
  • Collaborate with various stakeholders, including PV Quality, Medical Safety, QPPV, and PV Operations teams.

Required Skills and Qualifications:

  • Working knowledge of drug safety and risk management principles.
  • 5-8 years of industry experience and understanding of drug development, basic knowledge of regulatory guidelines, and medical coding.
  • Stakeholder management, strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.
  • Excellent organizational and project management abilities, strong communication and interpersonal skills, and ability to work effectively in a cross-functional, multicultural environment.
  • Evaluation, interpretation, and synthesis of scientific data, expertise in signal risk management, and proficiency in international regulations and guidelines.

Benefits:

  • A challenging role with opportunities for growth and development.
  • A collaborative and dynamic work environment.
  • The chance to work on cutting-edge projects and contribute to the advancement of pharmacovigilance practices.

Others:

  • PREFERRED HEALTHCARE DISCIPLINE DEGREE IN MODERN SCIENCE: MASTER OF PHARMACY, MASTER OF HEALTH SCIENCE, PHYSICIAN ASSISTANT, MBBS, BDS ETC
  • Languages: Fluent in English (verbal and written)


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