About Company
At Career.zycto, we empower healthcare and life sciences professionals to thrive in dynamic environments. For a Pharmacovigilance Specialist, this means a supportive, remote-first culture valuing meticulous data analysis and patient safety above all. We are a forward-thinking recruitment and HR solutions partner, dedicated to connecting top talent with groundbreaking opportunities. Our focus is on fostering careers where expertise makes a tangible difference, ensuring our clients — and the patients they serve — benefit from exceptional skill and dedication. Join a team where your vigilance is celebrated and your contributions are pivotal to global health outcomes.
Job Description
We are seeking a highly motivated and detail-oriented Pharmacovigilance Specialist to join our client’s remote team, operating from the Longsight, Manchester area. This critical role involves ensuring the safety of medicinal products through comprehensive monitoring, assessment, and reporting of adverse drug reactions (ADRs). As a Pharmacovigilance Specialist, you will be instrumental in safeguarding patient health and maintaining regulatory compliance within the pharmaceutical industry. You will handle individual case safety reports (ICSRs), contribute to aggregate reports, and collaborate with cross-functional teams to uphold the highest standards of drug safety. This is an exciting opportunity for an individual passionate about making a tangible impact on patient outcomes, working from the comfort of their home office.
You will be responsible for the end-to-end processing of adverse event reports from various sources, including clinical trials, post-marketing surveillance, and literature. This involves data entry, medical coding using MedDRA, causality assessment, and narrative writing. A strong understanding of global pharmacovigilance regulations (e.g., ICH guidelines, EMA regulations, FDA regulations) is essential to excel in this role. We pride ourselves on fostering a culture of continuous learning and professional development, ensuring our specialists are always at the forefront of pharmacovigilance science. Your expertise will directly contribute to identifying potential safety signals and informing crucial risk management strategies for life-saving therapies. This role offers the flexibility of remote work, allowing you to manage your responsibilities efficiently while contributing to vital public health initiatives from anywhere within the UK.
Key Responsibilities
- Process, review, and assess individual case safety reports (ICSRs) from various sources, ensuring accuracy and compliance with regulatory requirements.
- Perform medical coding of adverse events and medical history using MedDRA and drugs using WHODrug dictionaries.
- Conduct causality assessments and generate compelling narratives for ICSRs.
- Assist in the preparation and review of aggregate safety reports, such as PSURs, DSURs, and RMPs.
- Maintain up-to-date knowledge of global pharmacovigilance regulations, guidelines, and industry best practices.
- Collaborate effectively with clinical, regulatory, medical affairs, and quality assurance teams.
- Participate in safety signal detection and risk management activities.
- Respond to safety-related queries from internal and external stakeholders.
- Contribute to the development and update of pharmacovigilance standard operating procedures (SOPs) and work instructions.
- Ensure timely and accurate submission of safety reports to regulatory authorities.
Required Skills
- Proven experience (minimum 3 years) in pharmacovigilance within a pharmaceutical company, CRO, or regulatory agency.
- In-depth knowledge of global pharmacovigilance regulations (e.g., ICH, EMA, FDA).
- Proficiency in safety databases (e.g., Argus, ArisG) and medical coding dictionaries (MedDRA, WHODrug).
- Excellent written and verbal communication skills in English.
- Strong analytical and problem-solving abilities with keen attention to detail.
- Ability to work independently in a remote setting and manage multiple priorities effectively.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Preferred Qualifications
- Bachelor's or Master's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
- Experience with signal detection and risk management plan activities.
- Prior experience working with global teams or in a multi-national environment.
- Certification in Pharmacovigilance or a related field.
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and public holidays.
- Flexible remote work environment.
- Opportunities for professional development and continuous learning.
- Employer-matched pension contributions.
- Access to cutting-edge pharmacovigilance tools and resources.
- Supportive and collaborative team culture.
How to Apply
Interested candidates are encouraged to apply by clicking the link below. Please ensure your resume highlights your relevant pharmacovigilance experience and regulatory knowledge. We look forward to reviewing your application!
