Pharmaceutical Safety Specialist
hace 3 semanas
Company Overview
We are Azierta, a pharmaceutical consulting firm and partner of life sciences companies. Our global support for clients includes the development, transformation, and integral management of their products and services, ensuring premium quality consulting that benefits patients worldwide.
Salary Package
We offer an attractive and competitive salary tailored to individual needs, adhering to local laws and regulations.
Job Description:
A Drug Safety Officer with veterinary background and at least 3 years of experience is required. The ideal candidate will have a Master's degree in the pharma industry.
Responsibilities:
Check compliance with deadlines and work methodology established in pharmacovigilance agreements/contracts between Azierta and clients. Perform quality control of Pharmacovigilance activities, including case management, reconciliations, authority information searches, and medical information management. Prepare and review reports and signal detection analysis. Develop and review Pharmacovigilance System Master Files (PSMF) and customer pharmacovigilance standard operating procedures (SOPs/WI). Review Azierta's SOPs to ensure they meet customer requirements. Develop and review pharmacovigilance agreements between Azierta and customers. Support inspections and audits. Evaluate the CAPA plan applicable to projects. Manage Quality activities related to customer Pharmacovigilance activities. Act as project manager for different clients, controlling delegated Pharmacovigilance activities (internal and external).
Required Skills and Qualifications:
We look for individuals with a Master's degree in the pharmaceutical industry, a minimum of 3 years' experience in drug safety officer positions with a background in veterinary drugs. A resilient attitude, hunger for knowledge, and innovative problem-solving skills are essential. The ability to be straightforward yet respectful is valued.
Benefits:
QbD Group offers job security, a continuous learning journey, and meaningful connections. As an award-winning company, we celebrate achievements and value everyone's contribution.
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