TL-Pharmacovigilance

3 weeks ago

Mumbai, India Cognizant Full time

Job Summary

We are seeking an experienced professional for the role of TL-Pharmacovigilance with 6 to 9 years of experience. The ideal candidate will have expertise in Pharma Research & Development and proficiency in MS Excel. Experience in PV Case Processing and Pharmacovigilance & Safety Ops is advantageous. The role involves working in a hybrid model with rotational shifts.

Responsibilities

  • Lead pharmacovigilance activities to ensure compliance with regulatory requirements and company standards.
  • Oversee the collection assessment and reporting of adverse event data to maintain patient safety.
  • Provide expert guidance on pharmacovigilance processes and ensure timely case processing.
  • Collaborate with cross-functional teams to enhance safety operations and improve efficiency.
  • Utilize MS Excel to analyze data and generate reports for stakeholders.
  • Monitor trends in safety data and recommend actions to mitigate potential risks.
  • Ensure accurate documentation and maintenance of pharmacovigilance records.
  • Develop and implement strategies to optimize pharmacovigilance workflows.
  • Conduct training sessions to enhance team knowledge and skills in safety operations.
  • Support the development of pharmacovigilance policies and procedures.
  • Engage with external partners to align on safety standards and practices.
  • Contribute to the continuous improvement of pharmacovigilance systems and tools.
  • Participate in audits and inspections to ensure compliance with industry regulations.

Qualifications

  • Possess a strong background in Pharma Research & Development with a focus on safety.
  • Demonstrate proficiency in MS Excel for data analysis and reporting.
  • Experience in PV Case Processing is highly desirable.
  • Familiarity with Pharmacovigilance & Safety Ops is a plus.
  • Ability to work effectively in a hybrid model with rotational shifts.
  • Strong analytical and problem-solving skills.
  • Excellent communication and collaboration abilities.

Certifications Required

Certification in Pharmacovigilance or Drug Safety is preferred.

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