Pharmacovigiliance

Firstcall Hresource; Bengaluru; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Firstcall Hresource in Bengaluru is seeking a pharmacovigilance specialist to conduct thorough case processing, medical summarization, and signal detection from adverse event reports.

You will collaborate with cross-functional teams to investigate drug safety issues, provide expert PV strategies to stakeholders, and maintain records that ensure regulatory compliance.

Qualifications

• 2–19 years of experience in pharmacovigilance or clinical trials management.
• Strong knowledge of drug safety principles, regulations (ICH E2C), and industry standards (FDA guidelines).
• Proficiency in ADR reporting tools; knowledge of other relevant terminologies an asset.

Responsibilities

• Conduct thorough case processing, medical summarization, and signal detection to identify potential safety signals from adverse event reports.
• Collaborate with cross-functional teams to investigate and resolve issues related to drug safety.
• Provide expert advice on pharmacovigilance strategies and best practices to internal stakeholders.
• Develop and maintain accurate records of all safety-related activities, ensuring compliance with regulatory requirements.

Skills

Pharmacovigilance

Adverse event reporting

MedDRA coding

Regulatory compliance

Data analysis

Tools

MedDRA coding system

ADR reporting databases

Job description

Roles and Responsibilities :

• Conduct thorough case processing, medical summarization, and signal detection to identify potential safety signals from adverse event reports.
• Collaborate with cross-functional teams to investigate and resolve issues related to drug safety.
• Provide expert advice on pharmacovigilance strategies and best practices to internal stakeholders.
• Develop and maintain accurate records of all safety-related activities, ensuring compliance with regulatory requirements.

Job Requirements :

• 2-19 years of experience in pharmacovigilance or a related field (e.g., clinical trials management).
• Strong understanding of drug safety principles, regulations (e.g., ICH E2C), and industry standards (e.g., FDA guidelines).
• Proficiency in ADR reporting tools such as MedDRA coding system; knowledge of other relevant terminologies an asset.
• Excellent analytical skills for managing large datasets, identifying trends, and developing actionable insights.