Specialist Pharmacovigilance

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd is seeking a detail-oriented professional to review, evaluate, and assign incoming Product Quality Complaints (PQCs) in a fast-paced environment. The role requires strong knowledge of PQC processes for pharmaceutical, biological, devices, and combination products.

You will collaborate with stakeholders to ensure timely intake, triage, and escalation, delivering high-quality investigation reports for QA approval and maintaining regulatory awareness throughout the

Qualifications

• Degree/Certification/Licensure
• Bachelor of Science (Life Sciences, Pharmacy, Nursing, Chemical or Bio-Engineering or related field)
• Required Competencies
• Fluent in English, with proven professional working proficiency in English for reading, writing and speaking
• Excellent communication with management, peers, and other functional areas
• In-depth understanding of global regulatory environment with respect to Product Quality Complaint processing

Responsibilities

• Responsible for accurate & timely review, evaluation and assignment of incoming Product Quality Complaints (PQCs) in a fast-paced, high-volume, high-complexity environment within established performance requirements (within one business day, >99% Right First Time).
• Responsible to maintain high level knowledge and understanding of applicable procedures appropriate to processing of Product Quality Complaints for BMS products (Pharmaceutical, Biological, Devices, Combination products).
• Responsible to maintain expert knowledge and understanding of PQC intake routes and maintain collaborative partnerships with stakeholders for intake of PQCs.
• Responsible to manage PQC mailboxes as a source of intake for PQCs.
• Responsible to maintain knowledge of BMS product network, product portfolio, and PQC defect categories with respect to BMS products, commensurate to delivery of timely and right first time processing of Product Quality Complaints frm receipt and through to investigation assignment.
• Ensure that critical thinking and risk-appropriate timelines are applied to the triage and processing of PQCs. Expedite category complaints will be managed with due urgency. Responsible to deliver timely escalations to investigation sites, market quality, and senior management as appropriate.
• Responsible to liaise with investigation sites to deliver high quality, on-time, comprehensive investigation reports for BMS Quality approval

Skills

PQC knowledge

English proficiency

Communication skills

Regulatory knowledge

Education

Bachelor of Science

BSc Life Sciences

Job description

Responsibilities

• Responsible for accurate & timely review, evaluation and assignment of incoming Product Quality Complaints (PQCs) in a fast-paced, high-volume, high-complexity environment within established performance requirements (within one business day, >99% Right First Time).
• Responsible to maintain high level knowledge and understanding of applicable procedures appropriate to processing of Product Quality Complaints for BMS products (Pharmaceutical, Biological, Devices, Combination products).
• Responsible to maintain expert knowledge and understanding of PQC intake routes and maintain collaborative partnerships with stakeholders for intake of PQCs.
• Responsible to manage PQC mailboxes as a source of intake for PQCs.
• Responsible to maintain knowledge of BMS product network, product portfolio, and PQC defect categories with respect to BMS products, commensurate to delivery of timely and right first time processing of Product Quality Complaints frm receipt and through to investigation assignment.
• Ensure that critical thinking and risk-appropriate timelines are applied to the triage and processing of PQCs. Expedite category complaints will be managed with due urgency. Responsible to deliver timely escalations to investigation sites, market quality, and senior management as appropriate.
• Responsible to liaise with investigation sites to deliver high quality, on-time, comprehensive investigation reports for BMS Quality approval

Qualifications & Experience

• Degree/Certification/Licensure
• Bachelor of Science (Life Sciences, Pharmacy, Nursing, Chemical or Bio-Engineering or related field)
• Required Competencies
• Fluent in English, with proven professional working proficiency in English for reading, writing and speaking
• Excellent communication with management, peers, and other functional areas
• In-depth understanding of global regulatory environment with respect to Product Quality Complaint processing