21 Aug
|
OrciMed Life Sciences Private
|
Hyderabad
21 Aug
OrciMed Life Sciences Private
Hyderabad
Company Description OrciMed Life Sciences Private Limited is a quality-driven Clinical Services Organisation (CSO) focused on cost-effective drug development and commercialisation. Built on strategic excellence and strong scientific expertise, the company aims to be an indispensable global player in the healthcare and Clinical Research Organisation (CRO) industry. OrciMed transforms critical data and vital information into meaningful value propositions to support better patient outcomes and informed decision-making. The team is committed to meeting customer requirements with strict adherence to timelines, persistent flexibility, and high quality standards. Professionals joining OrciMed can expect a science-led, collaborative environment with opportunities to contribute to innovative healthcare solutions.
Role Description This is a full time, on-site role based in Hyderabad, covering key functions in Drug Safety, Biostatistics, Statistical Programming, and Pharmacovigilance (PV) Quality Assurance.
Day-to-day responsibilities for the Drug Safety Physician include medical review of adverse event reports, signal detection activities, risk–benefit assessment, and preparation of safety-related regulatory documents. Biostatistician responsibilities include designing statistical analysis plans, supporting protocol development, performing and validating statistical analyses, and contributing to clinical study reports and publications. Statistical Programmers will develop, test, and maintain programs (e.g., using SAS or R) for data manipulation, analysis datasets, tables, listings, and figures, ensuring regulatory-compliant documentation. PV QA responsibilities include planning and conducting pharmacovigilance audits, oversight of quality systems, SOP compliance checks, and supporting inspection readiness and CAPA implementation. All team members will collaborate cross-functionally with clinical, regulatory, data management, and safety operations to ensure high-quality, compl
📌 Drug Safety Physician, Biostatistician, statistical programmer, PV QA (Hyderabad)
🏢 OrciMed Life Sciences Private
📍 Hyderabad