Drug Safety Associate

Role Overview

Purpose of 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.

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 6 years of pharmaceutical/CRO experience with focus on safety related areas in clinical trial is required.

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 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.
  
  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 one 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 in clinical research and biotech, including people who identify with LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to responding to every application. We look forward to talking to you about working at Novotech.