Drug Safety Associate – Remote
About Company At Career.zycto, we are pioneering advancements in health, driven by a commitment to patient well-being and regulatory excellence. We empower Drug Safety Associates to take ownership of critical pharmacovigilance activities, ensuring every data point contributes to a safer world. This is a place where your analytical skills and meticulous attention to detail are not just valued, but are essential to our collective success. Join a dynamic team where your contributions directly impact global health, fostering an environment of continuous learning and professional growth within a supportive, forward-thinking culture dedicated to scientific integrity.
Job Description
Career.zycto is seeking a meticulous and dedicated Drug Safety Associate to join our growing pharmacovigilance team. This remote position offers an exciting opportunity to contribute to patient safety from the comfort of your home, while collaborating with a vibrant team across the UK. As a Drug Safety Associate, you will play a crucial role in processing and managing individual case safety reports (ICSRs) from various sources, ensuring compliance with global regulatory requirements and internal standard operating procedures. Your work will directly impact the safety profile of medicinal products, safeguarding public health. We are looking for an individual with a keen eye for detail, strong analytical capabilities, and a foundational understanding of pharmacovigilance principles. You will be responsible for the timely and accurate data entry, coding, and quality control of adverse event reports. This includes narrative writing, MedDRA coding, and preparing reports for submission to regulatory authorities. The role requires a proactive approach to problem-solving, excellent communication skills for interacting with internal teams and external stakeholders, and a commitment to continuous learning in the dynamic field of drug safety. If you are passionate about contributing to a safer healthcare landscape and thrive in a remote work environment, we encourage you to apply and become an integral part of our mission.
Key Responsibilities
- Perform accurate and timely data entry of adverse event reports into the safety database.
- Conduct thorough case processing, including narrative writing, MedDRA coding, and causality assessment.
- Ensure all adverse event reports comply with regulatory requirements and internal SOPs.
- Assist in the preparation and submission of individual case safety reports (ICSRs) to regulatory authorities.
- Perform quality control checks on processed cases to ensure data integrity and accuracy.
- Communicate effectively with reporters and healthcare professionals to obtain necessary follow-up information.
- Participate in ongoing training and professional development to stay current with pharmacovigilance regulations and guidelines.
- Contribute to the continuous improvement of pharmacovigilance processes and systems.
- Maintain confidentiality and adhere to data privacy regulations. Required Skills
- Minimum of 2 years of experience in pharmacovigilance or drug safety.
- Strong understanding of ICH-GCP guidelines and global pharmacovigilance regulations (e.g., EMA, FDA).
- Proficiency in safety database systems (e.g., Argus, ArisG).
- Excellent written and verbal communication skills in English.
- Exceptional attention to detail and strong organizational skills.
- Ability to work independently and as part of a remote team.
- Proficiency in medical terminology and MedDRA coding.
- Strong analytical and problem-solving abilities.
Preferred Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related healthcare field.
- Experience with aggregate report generation.
- Previous experience in a remote work setting.
- Familiarity with signal detection activities. Perks & Benefits
- Competitive salary and benefits package.
- Fully remote work flexibility.
- Opportunities for professional growth and continuous learning.
- Comprehensive health and wellness programs.
- Generous paid time off and holiday allowance.
- Supportive and collaborative team environment.
- Contribution to meaningful work that impacts global patient safety.
How to Apply
To apply for this exciting opportunity, please click on the application link below. Ensure your resume highlights your relevant pharmacovigilance experience and commitment to patient safety. Apply To this Job