Become a Drug Safety Associate at Novotech – Apply Today!

Novotech is actively seeking candidates for the role of Drug Safety Associate at its Bengaluru location. This is a key position for individuals passionate about pharmacovigilance and ensuring the safety of pharmaceuticals in clinical trials.

Drug Safety Associate

Job Description

 Brief Position Description:

“Drug Safety Associate” will be responsible for complete and accurate case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations. 

Minimum Qualifications & Experience:

• Registered nurse/pharmacist or with health/biomedical degree or other related scientific degree/ qualification is required. 
• A minimum of 2 years safety-related experience in a pharmaceutical company/CRO environment is required. 
• At Novotech, the individual should have completed a minimum of 2 years in Drug safety associate role. 
• Have understood the processes and are ready to take on additional responsibilities. 

Responsibilities:

Overall responsible for drug safety reporting aspects of Novotech’ s business including.

Configuring/ reviewing of applicable safety database with study-specific information.

Preparing and reviewing study-specific safety management plan and related tools per client requirements, SOP, and guidelines.

Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness, triage of incoming cases to prioritize for daily workflow management, completion of narrative, manual coding, approval, and reconciliation of safety data.

Liaison with medical monitors/drug safety physicians, clients, and study teams as appropriate to clarify appropriate information required for case processing.

Prioritization of data entry activities for cases by reference to the date of receipt in accordance with SOPs and guidelines.

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