SME_Pharmacovigilance

Orcapod Consulting Services; Pune District, Mumbai, Bengaluru; In loco; INR 300.000 - 420.000; Tempo pieno

Descrizione del lavoro

Orcapod Consulting Services seeks a pharmacovigilance professional to handle adverse event reports and ensure accurate ICSR documentation. The role requires reviewing patient and drug information, plus performing medical coding per guidelines to support compliance and quality targets.

The candidate will contribute to PV processes, use safety databases effectively, and provide SME guidance to teammates, adapting to process requirements and shifts as needed.

Competenze

• 1+ year of pharmacovigilance experience and familiarity with ICSR processes.
• Understanding of adverse event case processing and PV workflows.
• Knowledge of safety databases and PV processes, with strong communication skills.

Mansioni

• Handle and review adverse event safety case reports.
• Perform ICSR processing and ensure accurate case documentation.
• Review patient, drug, and adverse event information.
• Perform medical coding and case assessment as per guidelines.
• Support case quality checks and ensure SOP/regulatory compliance.
• Identify and escalate discrepancies or missing information.
• Support the team in meeting quality and productivity targets.
• Provide SME guidance to team members and respond to process queries.

Conoscenze

Pharmacovigilance experience

ICSR processing

Adverse event processing

Safety databases knowledge

Communication & analytics

Descrizione del lavoro

Key Responsibilities:

• Handle and review adverse event/safety case reports.
• Perform ICSR processing and ensure accurate case documentation.
• Review patient, drug, and adverse event information.
• Perform medical coding and case assessment as per applicable guidelines.
• Support case quality checks and ensure compliance with SOPs and regulatory requirements.
• Identify and escalation discrepancies or missing information.
• Support the team in meeting quality and productivity targets.
• Provide SME-level guidance to team members and support process-related queries.

Preferred candidate profile

• 1+ year of relevant Pharmacovigilance experience
• Good understanding of ICSR / Adverse Event case processing
• Knowledge of safety databases and PV processes
• Good communication and analytical skills
• Ability to work as per process requirements/shifts, if applicableRole & responsibilities