Job Description

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Brief Position Description: 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:

• A minimum of 1- 3years of industry and/or clinical experience with focus on safety related areas is required.
• Experience in Safety management plan (SMP) or risk management plan (RMP).
• Should have processed SUSAR cases.
• Should have done any ICSR unblinding.
• Knowledge of coding applications, safety databases, processes and tools is preferred.
• Thorough knowledge of medical terminology and ability to summaries medical information is required.
• Strong computer proficiency and ability to work in specific databases is required.
• Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred.

Responsibilities:

Manage project-specific activities which may include:

• Preparation of safety management plan, preparing safety DB configuration documents for each project; preparing slides for project kick off meetings.
• Case processing activities and drafting safety narratives including quality review to ensure accuracy and completeness, filing study documents in TMF.
• Manages unblinding procedures, where applicable, including creation of clear SOP; integration with information technology to ensure effective implementation of the unblinding SOP across safety database and IT systems.
• Monitoring of the safety mailbox.
• Conducting literature searches and monitor for adverse event reports as well as monitor post approval commitments.
• Participate in clinical study reconciliation activities, as requested by client.
• Liaison with medical monitors/ drug safety physicians, clients, and study teams as appropriate to clarify information required for case processing.
• Participation in inspection/ audit related activities; Assistance in preparation or implementation of corrective/ preventative actions relating to case processing.
• Timely submission of reports to regulatory agencies in accordance with applicable regulations and tracking the details of submissions for compliance.
• Preparation and submission of periodic safety reports such as DSUR/PSUR, per the study requirements.
• Provision of on-the-job training and mentoring of junior Staff; Act as key contact or point of expertise for team members and external contacts for designated projects/processes; Takes lead in updating country reference manual; Act as a subject matter expert.
• Support PV management in PV implementation activities.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

About Us: Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.

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.

About the Team: 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.

As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

Novotech