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, team-oriented 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, compliant deliverables.

Qualifications

- Drug safety and clinical expertise, including experience in pharmacovigilance case processing, signal detection, and medical review (MBBS/MD or equivalent for Drug Safety Physician preferred).
- Biostatistics knowledge, with experience in study design, statistical methodologies, and interpretation of clinical trial data (Master’s degree in Biostatistics/Statistics or related discipline desirable).
- Statistical programming proficiency in tools such as SAS, R, or Python for clinical data analysis, dataset creation, and generation of tables, listings, and figures.
- PV quality assurance skills, including audit planning and execution, SOP and process compliance, inspection readiness, and CAPA management.
- Strong understanding of ICH-GCP, Good Pharmacovigilance Practices (GVP), and global regulatory requirements (e.g., FDA, EMA) relevant to drug safety and clinical research.
- Excellent analytical, problem-solving, and documentation skills, with high attention to detail and data integrity.
- Effective written and verbal communication skills, with the ability to collaborate in cross-functional and multicultural teams.
- Relevant industry experience

📌 Drug Safety Physician, Biostatistician, statistical programmer, PV QA (Hyderabad)
🏢 OrciMed Life Sciences Private
📍 Hyderabad