Job opportunity for Drug Safety Associate at Novotech- Apply before 10th August 2024

About Novotech

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

Job Title: Drug Safety Associate

Brief Position Description

Purpose: The Senior Pharmacovigilance Associate role is pivotal in monitoring and managing the safety aspects of clinical studies and post-marketing surveillance. This includes tasks such as monitoring the safety mailbox, preparing safety management plans, setting up safety databases for studies, processing and submitting ICSRs (SAE/SUSAR/AEs), and preparing and submitting periodic reports. All activities must comply with ICH-GCP, SOPs, and applicable regulatory requirements. The role also involves assisting in developing and implementing best-in-class policies, procedures, and practices within safety management.

Responsibilities

• Comprehensive knowledge of clinical trials and pharmacovigilance requirements.
• Familiarity with international drug safety regulatory reporting obligations and compliance.
• Preferred experience in coding medical terminologies, case processing, and safety report submission.
• Strong understanding of medical terminology and the ability to summarize medical information.
• High computer proficiency with the ability to work in specific databases.
• Adherence to guidelines and procedural documents, including SOPs.
• Fluent in both written and oral English.
• Excellent interpersonal skills for professional communication at all organizational levels.
• Effective time management and multi-tasking capabilities.

Candidate Profile

• 6 months to 2 years of pharmaceutical/CRO/clinical knowledge or experience with a focus on safety-related areas in clinical trials.

Additional Information

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