Novotech Pharmacovigilance Drug Safety Associate Job Openings at Bangalore, Karnataka
Novotech is the Asia-Pacific CRO designed for biotech, accelerating clinical development via cutting-edge technology to improve patient lives.
About the Opportunity :
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
- Overall responsible for drug safety reporting aspects of Novotech’s business including:
- Configuring of applicable safety database with study-specific information
- Preparing 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 prioritise 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
- Prioritisation of data entry activities for cases by reference to the date of receipt in accordance with SOPs and guidelines
- Processing adverse event reports and maintaining safety database and tracking systems and preparing reports for regulatory authorities as required
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.
- Knowledge and experience in international drug safety-regulatory reporting obligations and compliance, coding applications, case processing, safety processes and tools is preferred.
- Good knowledge of medical terminology, ability to write clear, concise, unambiguous medical text is required.
- Ability to acquire knowledge in different disease and therapeutic areas, fluency in English, ability to evaluate data and draw conclusions independently, ability to follow
- guidelines and procedural documents (experience of working with SOPs) is preferred;
- Computer proficiency and ability to work in specific safety databases (e.g. Argus) is essential.
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