Cognizant Hiring for Pharmacovigilance

Orcapod Consulting Services is hiring for the position of SME – Pharmacovigilance in Pune, Mumbai, and Bengaluru. Candidates with at least one year of relevant pharmacovigilance experience and knowledge of Individual Case Safety Report (ICSR) processing, safety databases, and drug safety processes can apply.

Job Details

Positions

Subject Matter Expert (SME) – Pharmacovigilance

The role involves reviewing adverse event reports, processing safety cases, performing medical coding, ensuring case quality, and providing process-related guidance to team members.

Roles and Responsibilities

• Handle and review adverse event and safety case reports.
• Process Individual Case Safety Reports (ICSRs) and maintain accurate case documentation.
• Review patient, drug, and adverse event information.
• Perform medical coding and case assessment according to applicable guidelines.
• Conduct case quality checks and ensure compliance with SOPs and regulatory requirements.
• Identify and escalate discrepancies or missing information.
• Support the team in meeting quality and productivity targets.
• Provide subject matter expertise and resolve process-related queries.

Eligibility and Qualifications

• Educational Qualification: B.Pharm, M.Pharm, or Pharm.D.
• Experience: At least one year of relevant pharmacovigilance experience.
• Good understanding of ICSR and adverse event case processing.
• Knowledge of safety databases and pharmacovigilance processes.
• Ability to work according to process requirements and shifts, if applicable.

Required Skills

• Pharmacovigilance
• Drug Safety
• ICSR Processing
• Adverse Event Case Processing
• Medical Coding
• Case Assessment and Quality Review
• Safety Databases
• Veeva
• Argus
• SOP and Regulatory Compliance
• Communication and Analytical Skills