Novotech is a leading Contract Research Organization (CRO) known for providing comprehensive services in the biotechnology and clinical research sectors. With a global presence, the company specializes in offering innovative and flexible solutions to help clients accelerate their clinical trials. Novotech’s commitment to gender equality, inclusivity, and a supportive workplace makes it a top choice for professionals looking to work in a dynamic and progressive environment. The company prides itself on offering flexible working options, paid parental leave, wellness programs, and opportunities for career development.
Responsibilities in Job: Pharmacovigilance Associate
As a Pharmacovigilance Associate, you will play a crucial role in ensuring the safety of clinical trials and post-marketing surveillance. Your primary responsibilities will include:
- Safety Management: Preparation of safety management plans, safety database configurations, and slides for project kick-off meetings.
- Case Processing: Process and submit Individual Case Safety Reports (ICSRs) such as SAE, SUSAR, and AEs in compliance with ICH-GCP, SOPs, and regulatory requirements.
- Monitoring & Reporting: Monitor safety mailboxes, perform literature searches, and track adverse event reports. Ensure timely submission of reports to regulatory agencies and track compliance.
- Collaboration: Work closely with medical monitors, drug safety physicians, clients, and study teams to ensure accurate case processing.
- Study Reconciliation: Participate in clinical study reconciliation activities, as required.
- Audit and Inspection: Assist in audit and inspection activities and support corrective/preventive actions related to case processing.
- Training: Provide on-the-job training and mentoring to junior staff.
Qualifications
To qualify for the Pharmacovigilance Associate role at Novotech, candidates should possess the following qualifications:
- Education: A registered nurse, pharmacist, or a degree in health/biomedical sciences or a related field is required. Postgraduate qualifications or certification in clinical trials will be advantageous.
- Experience: 2 to 4 years of pharmaceutical or CRO experience, specifically in safety-related areas within clinical trials.
- Skills:
- Proficient in medical terminology and case processing.
- Knowledge of international drug safety-regulatory reporting obligations.
- Familiarity with coding medical terminologies.
- Experience working with SOPs and in compliance with guidelines.
- Strong computer skills, including proficiency in databases.
- Excellent time management and multi-tasking capabilities.
Skills
A successful candidate for the Pharmacovigilance Associate position will have the following skills:
- Medical Knowledge: A thorough understanding of medical terminology and clinical trials, with the ability to summarize and process medical information accurately.
- Communication: Fluency in both written and spoken English with excellent interpersonal skills to communicate effectively with colleagues at all levels.
- Problem Solving: Ability to follow guidelines and procedural documents to ensure compliance with regulatory requirements.
- Time Management: Strong ability to prioritize tasks and handle multiple responsibilities simultaneously.
