QPPV (Nashik)

QPPV (Nashik)

02 Sep
|
S N SCORT RESEARCH SOLUTIONS
|
Nashik

02 Sep

S N SCORT RESEARCH SOLUTIONS

Nashik

Company Description SN SCORT Research Solutions Pvt. Ltd. is a Life Sciences and Healthcare research organization specializing in Pharmacovigilance, Drug Safety, Clinical Research, and Site Management Organization (SMO) services. The company supports pharmaceutical and biotechnology organizations, CROs, hospitals, medical device companies, and research partners with quality-focused, compliant, and timely solutions.

Its pharmacovigilance services span end-to-end safety case management, medical review, literature monitoring, safety surveillance, signal detection support, aggregate reporting, and PV compliance.

Clinical

Research and SMO services include clinical trial coordination, site management, patient recruitment, data collection, safety reporting, and overall research site operations. With a strong commitment to “Patient Safety First,” the organization aims to build long-term partnerships in India and globally while contributing to safer healthcare.

Role Description The Qualified Person for Pharmacovigilance (QPPV) will be responsible for the overall pharmacovigilance system, ensuring that all drug safety activities comply with applicable regulatory requirements and company standards. This full-time on-site role, based in Nashik, involves oversight of safety case management, review of adverse event and serious adverse event reports, signal detection activities, and periodic safety and aggregate reports. The QPPV will collaborate closely with safety physicians, PV operations teams, clinical research staff, and external partners to maintain robust safety governance and continuous process improvement.





Daily tasks include ensuring timely submission of regulatory reports, monitoring literature and safety data, providing medical and scientific input on safety issues, and supporting audits and inspections. The role also includes training and mentoring team members on pharmacovigilance procedures and fostering a culture of patient safety and compliance.

Qualifications

- Candidates should possess strong expertise in pharmacovigilance and drug safety, including safety case management, adverse event handling, signal detection, and aggregate safety reporting.
- Candidates should possess solid knowledge of regulatory requirements and compliance frameworks for PV, including global and local guidelines, inspection readiness, audit support, and quality management.
- Candidates should possess clinical and medical competencies relevant to patient safety, such as clinical assessment skills, understanding of therapeutic areas, and the ability to interpret medical data in safety contexts.
- Candidates should possess analytical and research skills, including data analysis, literature review, critical thinking, and the ability to support evidence-based safety decisions.
- Candidates should possess strong communication and documentation skills, including explicit medical writing for narratives and reports, stakeholder communication, and the ability to present safety findings to internal and external audiences.
- Candidates should possess leadership and collaboration abilities, with experience in guiding PV teams, coordinating cross-functional activities, managing timelines, and supporting a culture of accountability and continuous improvement.
- Relevant professional degree in

📌 QPPV (Nashik)
🏢 S N SCORT RESEARCH SOLUTIONS
📍 Nashik

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