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.
- Expertise in international drug safety regulatory reporting obligations/ compliance, end to end case processing, client communication, and data reconciliation.
- 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.
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.
- Processing adverse event reports and maintaining safety database and tracking systems and preparing reports for regulatory authorities as required.
- Timely submission of reports to regulatory agencies in accordance with applicable regulations and that all inquiries from the regulatory agencies are responded to in a timely manner and tracking the details of submissions for compliance.
- Participation in assigned projects, including inspections and audit readiness activities, including interviews and provision of requested data.
- Participation in local or global project teams, including on-time delivery of assigned responsibilities.
- Proactively and timely communication of any issues relating to the pharmacovigilance processes.
- Conducting literature searches and monitor for adverse event reports as well as monitor post approval commitments.
- Continuous development of personal skills whether task or competency-related, including project finances, technical training, shadowing and/or mentoring others, soft-skill development.
- Maintaining compliance with company guidelines and HR Policies.
- Performing other related duties as required.
- Oversight and support as mentor to junior staff in managing projects assigned to them.
- Should have an expertise in monitoring the regulatory requirements of expedited ICSR and periodic reports (DSUR/PSUR/PBRER).
- Takes lead in updating country reference manual.
- Act as a subject matter expert.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
