Job Description

:Purpose of Pharmacovigilance Associate Role:The purpose of the Pharmacovigilance Associate role is to monitor and manage the safety aspects of clinical studies/post-marketing surveillance including but not limited to monitoring safety mailbox, preparation of safety management plan, setting up safety database for studies, processing & submission of ICSRs (SAE/SUSAR/AEs) in accordance with ICH-GCP, SOPs and applicable regulatory requirements/ensure compliance with regulations.Major Responsibilities:Describe the tasks, duties, and responsibilities the employee who is working on this role is supposed to carry out. List the responsibilities in the order of their importance.Pharmacovigilance Associate

• 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, monitoring of safety mailbox, filing study documents in TMF.
• Manages unblinding procedures.
• 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.
• Provision of on-the-job training and mentoring of junior staff.

Qualifications & Experience:State the education qualifications required along with the desired experience level. Mention specific skills and certifications which the candidate should have to apply for the role.Education

• Registered nurse/pharmacist or with health/biomedical degree or other related scientific degree/qualification is required.
• Postgraduate qualifications or certification in clinical trials will be an advantage.

Knowledge, Skills, and Abilities (Pharmacovigilance Associate)

• Knowledge of clinical trials and pharmacovigilance requirements. Knowledge/experience in international drug safety-regulatory reporting obligations and compliance.
• Experience in coding medical terminologies, case processing, safety report submission is preferred.
• Thorough knowledge of medical terminology and ability to summarise medical information is required.
• Strong computer proficiency and ability to work in specific databases is required/preferred.
• Ability to follow guidelines and procedural documents is required. Experience of working with SOPs etc. is required.
• Fluent in both written and oral English.
• Good interpersonal skill to professionally communicate with all levels of the organizations.
• Good time management & multi-task capability.

Experiences

• 2 years to 4 years of pharmaceutical/CRO experience with focus on safety related areas in clinical trial is required.

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 global full-service clinical Contract Research Organization (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.Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.

Novotech