SPE-Pharmacovigilance

4 days ago

Taguig, National Capital Region, Philippines Cognizant Full time $60,000 - $80,000 per year

Job Summary
Join our team as a Voice Specialist in Pharmacovigilance where you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products. With a focus on the clinical process you will contribute to the monitoring and evaluation of drug safety data. This hybrid role offers the opportunity to work both remotely and on-site providing flexibility and a dynamic work environment.

Responsibilities

  • Monitor and evaluate drug safety data to ensure compliance with regulatory standards and guidelines.
  • Collaborate with cross-functional teams to assess and report adverse drug reactions and safety concerns.
  • Utilize your expertise in the pharma clinical process to enhance the accuracy and efficiency of pharmacovigilance activities.
  • Conduct thorough case processing and documentation to support regulatory submissions and safety assessments.
  • Analyze safety data to identify trends and potential risks contributing to the development of risk management strategies.
  • Provide insights and recommendations to improve pharmacovigilance processes and ensure patient safety.
  • Support the development and implementation of pharmacovigilance systems and tools to streamline operations.
  • Engage in continuous learning and development to stay updated on industry trends and regulatory changes.
  • Work closely with research and development teams to integrate safety data into product development plans.
  • Ensure timely and accurate reporting of safety information to regulatory authorities and stakeholders.
  • Participate in audits and inspections to demonstrate compliance with pharmacovigilance regulations.
  • Contribute to the preparation of safety reports and risk assessment documents for internal and external use.
  • Foster a culture of safety and compliance within the organization promoting best practices in pharmacovigilance.

Qualifications

  • Possess a strong background in pharma clinical processes with a minimum of 3 years of experience.
  • Demonstrate expertise in PV case processing and familiarity with research and development activities.
  • Exhibit excellent analytical and problem-solving skills to assess and interpret safety data.
  • Show proficiency in using pharmacovigilance databases and tools for data management and reporting.
  • Display effective communication skills to collaborate with cross-functional teams and stakeholders.
  • Maintain a high level of attention to detail and accuracy in documentation and reporting.
  • Have a proactive approach to identifying and addressing potential safety issues.

Certifications Required
Certified Pharmacovigilance Professional (CPP) or equivalent certification in drug safety.

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