Novotech looking for Drug Safety Associate

Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services. It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.

Post : Drug Safety Associate

Brief Position Description :
Purpose of Senior Pharmacovigilance Associate role is to monitor and manage the safety aspects of clinical studies/ post marketing surveillance including but not limited to monitoring safety mailbox, preparation of safety management plan, setting up safety database for studies, processing & submission of ICSRs (SAE/SUSAR/AEs) and preparation of periodic reports & submission in accordance with ICH-GCP, SOPs and applicable regulatory requirements/ ensure compliance with regulations. Assist in developing and implementing best-in-class policies, procedures, and practices within safety management.

Responsibilities :
Knowledge of clinical trials and pharmacovigilance requirements. Knowledge/ experience in international drug safety-regulatory reporting obligations and compliance.
• Experience in coding medical terminologies, case processing, safety report submission is preferred
• Thorough knowledge of medical terminology and ability to summarise medical information is required.
• Strong computer proficiency and ability to work in specific databases is required/ preferred.
• Ability to follow guidelines and procedural documents is required. Experience of working with SOPs etc. is required.
• Fluent in both written and oral English.
• Good interpersonal skill to professionally communicate with all levels of the organizations.
• Good time management & multi-task capability.

Candidate Profile
• 6 months to 2 years of pharmaceutical/ CRO/ clinical knowledge/ experience with focus on safety related areas in clinical trial is required.

Additional Information
Experience : 6 months to 2 years
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Job Identification : 2650
End Date : 10th August 2024