Pharmacovigilance Specialist – Remote
About Company Seeking a stimulating environment where your expertise in drug safety can truly make a difference? Hiring.zycto offers exactly that – a dynamic platform for Pharmacovigilance Specialists to thrive. We are a forward-thinking organization dedicated to advancing patient safety through meticulous post-market surveillance and adverse event reporting. Our collaborative, remote-first culture fosters innovation and provides unparalleled flexibility, allowing you to contribute from anywhere while still being an integral part of a supportive team. Join us in our mission to ensure the safest possible outcomes for patients globally, shaping the future of pharmaceutical safety.
Job Description
Are you a meticulous and passionate Pharmacovigilance Specialist looking to leverage your expertise in a fully remote environment? Hiring.zycto invites you to join our dedicated team, playing a pivotal role in safeguarding public health globally. As a Pharmacovigilance Specialist, you will be instrumental in the end-to-end management of adverse event reports, from initial receipt to final submission, ensuring strict adherence to international and local regulatory requirements. This role demands a keen eye for detail, a deep understanding of pharmacovigilance principles, and the ability to critically assess drug safety data. You will contribute to the ongoing surveillance of medicinal products, identify potential safety signals, and support the development of risk management strategies. At Hiring.zycto, we are committed to fostering a culture of scientific rigor, continuous learning, and collaborative problem-solving, all while enjoying the flexibility and autonomy that remote work provides. This is an exceptional opportunity for a proactive individual eager to make a tangible impact on patient safety from anywhere in Canada. Your contributions will directly influence patient outcomes and contribute to the highest standards of drug safety.
Key Responsibilities
- Perform end-to-end processing of adverse event reports, including data entry, narrative writing, coding (MedDRA, WHODrug), and quality review.
- Conduct thorough causality assessment and seriousness determination for individual case safety reports (ICSRs).
- Ensure timely and accurate submission of ICSRs to regulatory authorities in compliance with global and local regulations.
- Participate in aggregate report preparation (e.g., PSURs, DSURs) by contributing to data collection and analysis.
- Monitor literature for potential safety concerns and new adverse event reports, assessing their relevance and reporting as required.
- Collaborate with internal and external stakeholders, including clinical teams, medical affairs, and regulatory affairs, to ensure comprehensive safety data management.
- Maintain up-to-date knowledge of global pharmacovigilance regulations, guidelines, and industry best practices.
- Contribute to the development and revision of Pharmacovigilance Standard Operating Procedures (SOPs) and work instructions.
- Support signal detection and risk management activities by contributing to the review and analysis of safety data.
- Participate in audits and inspections, providing necessary documentation and support. Required Skills
- Minimum of 3 years of experience in pharmacovigilance within the pharmaceutical, biotechnology, or CRO industry.
- In-depth knowledge of global pharmacovigilance regulations (e.g., ICH guidelines, FDA, Health Canada, EMA).
- Proficiency in adverse event case processing, including medical review, narrative writing, and coding with MedDRA and WHODrug dictionaries.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills in English.
- Ability to work independently and manage multiple tasks in a fast-paced, remote environment.
- Proficiency with pharmacovigilance databases and safety reporting systems (e.g., Argus, ArisG).
- Bachelor’s degree in a life science, pharmacy, nursing, or a related healthcare field.
Preferred Qualifications
- Master's degree or higher in a relevant scientific or medical discipline.
- Certified Pharmacovigilance Professional (CPP) or equivalent certification.
- Experience with signal detection and risk management plan development.
- Previous experience working in a fully remote or hybrid work model.
- Fluency in additional languages. Perks & Benefits
- Fully remote work model with flexible hours.
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and holiday schedule.
- Dedicated budget for professional development and continuous learning.
- Supportive and collaborative team culture.
- Opportunities for career advancement within a growing organization.
- Home office stipend and IT support.
How to Apply
Ready to make a significant impact on patient safety from the comfort of your home? We encourage all qualified candidates to click on the application link below to apply directly. Plea Apply To This Job Apply To this Job