Perform case processing and assessment of adverse event reports (AERs).

Ensure accurate coding using MedDRA and WHO Drug dictionaries.

Prepare individual case safety reports (ICSRs) and perform data entry in safety databases (Argus / ArisG).

Conduct literature screening for safety signals.

Support aggregate reports (PBRER, DSUR, RMP).

Ensure compliance with global regulatory timelines (EMA, US FDA, MHRA).

✨ About Novotech:
Novotech is a leading global Contract Research Organization (CRO) recognized for excellence in clinical trial management and innovation. We collaborate with top pharmaceutical and biotechnology companies to deliver high-quality research outcomes that shape the future of healthcare.

? Key Responsibilities:
Conduct site monitoring visits to ensure adherence to study protocols and compliance with regulatory guidelines.
Manage site communications and documentation, ensuring timely reporting of data and progress.
Review clinical trial data for accuracy, consistency, and completeness.

Oversees and manages clinical trials from start to finish. Responsible for project planning, budgeting, and resource allocation. Coordinates with clinical research teams, ensures compliance with regulatory standards, and manages relationships with stakeholders. Ensures data integrity and oversees the development of trial protocols and documentation.

Assists in studying the absorption, distribution, metabolism, and excretion of drugs. Requires background in pharmacokinetics and experience in laboratory research.

Supports sales teams in developing and implementing sales strategies, conducting market research, and analyzing sales data. Requires understanding of pharmaceutical products and sales processes.