ClinChoice is a global full-service Contract Research Organization dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Trainee, Case Processing (Safety) on a permanent basis.
Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!
Main Job Tasks and Responsibilities:
Read and acknowledge Individual Case Safety Report Pharmacovigilance trainings in the ClinChoice learning tool.
- Complete the mandatory training in the ClinChoice learning tool, immediately after the trainer's completion of the Instructor-Led Training for the corresponding topic.
- Address all questions using information available from reference documents.
- Meet weekly expectations during the training and mentoring phases.
- Review the material before quizzes/tests and be prepared for each session.
- Ensure the required threshold is met for all assessments.
- Schedule regular feedback and progress discussions with your mentor.
- Be receptive to feedback and address all assessment outcomes, providing feedback to the trainer and mentor as needed.
- Learn to receive and triage adverse event reports from various sources, such as Spontaneous, Literature, Regulatory, and Clinical Trials, ensuring accuracy and completeness of collected information.
- Prepare for each training topic, attempt assigned cases, and be ready to present.
- Gain familiarity with adverse event coding using Medical Dictionary for Regulatory Activities terminology.
- Learn to perform data validity checks, data encoding, and quality review processes under supervision.
- Practice drafting case narratives using standard templates, with oversight from a supervisor.
- Learn the basics of safety assessments, including seriousness, expectedness, and causality evaluations.
- Perform data entry in the training environment, including patient information, product details, causality, labelling and seriousness assessments, MedDRA coding for adverse events, medical history, laboratory findings, and drafting narratives.
- Ensure timely and accurate communication of reportable cases per regulatory timelines, under supervision.
- Complete case processing activities in the training environment within stipulated time frames, prioritizing allocated cases in accordance with service level agreements and regulatory timelines, while contributing to daily workflow management.
- Document work appropriately, complete timesheets, and participate in feedback sessions.
- Maintain awareness and understanding of relevant GVP modules and CFR guidelines.
- Stay informed about company procedures and guidelines to ensure regulatory compliance.
- Actively participate in PV meetings, discussions, and workshops.
- Complete all assigned trainings, both internal and client-initiated, within specified deadlines.
- Perform ad-hoc tasks as directed by the team lead/manager, ensuring quality and compliance as per project requirements.
- Be aware of and comply with the Privacy Policy, and report any potential or actual security breaches to the applicable distribution list.
Education and Experience:
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Nursing, Biotechnology, or related fields.
- Basic understanding of pharmacology, clinical research, or drug safety principles.
- Strong written and verbal communication skills in English.
- High level of accuracy in comprehending, reviewing and processing information.
- Familiarity with MS Office Suite (Word, Excel, PowerPoint) and general computer literacy
- Ability to handle multiple tasks and meet deadlines in a fast-paced environment.
Academic Program Detail:
- Program Anticipated Start Date: 13 Jan 2025
- Duration: 3 months
- Location: Onsite
- Attendance: 5 days a week
Our Benefits:
- Flexible Working Hours
- Full performance and development process with end of year reviews
- Employee satisfaction survey - your feedback is important for continuous improvement
- Health Insurance
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. To be considered for employment, you must successfully complete a three-month unpaid Academic Program. Which will be onsite in one of our offices twice a week. Academic Program anticipated start month November.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
