Arcolab QA Clinical Operations Position – Apply Only On Biotecnika
Company Name: – Arcolab
Role: Clinical Operations QA – Quality Assurance
Industry Type: Pharmaceutical & Life Sciences
Department: QA
Employment Type: Full Time, Permanent
Location: Bangalore
Mode of Interview: Face-to-Face / Virtual
Working Days: 5 Days a Week
CTC: ₹4–6 LPA (hike on current CTC if employed)
Vacancy: 2
Key Responsibilities:
• Monitor and ensure compliance with Pharmacovigilance (PV) processes and regulatory guidelines.
• Perform Quality Control reviews of ICSR (Individual Case Safety Reports), Aggregate Reports, and Signal Reports.
• Assist in preparation and review of Standard Operating Procedures (SOPs) related to PV activities.
• Support Medical Affairs in interpreting and implementing regulatory guidelines.
• Maintain data in tracking tools to analyze and present compliance trends.
• Assist in internal/external audit preparations and support during inspections.
• Contribute to implementation and compliance with ISO 27001 and ISO 27701 standards.
• Participate in risk management and CAPA related to PV functions.
Qualifications:
• UG/PG: Pharma related
• Prior experience in PV QA or related Pharmacovigilance domain is highly preferred.
Interview Process: Virtual and F2F
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