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Pharmacovigilance Compliance Specialist (M/F/D)
Tasks:
Review and medical assessment of adverse events reported from clinical trials and post-marketing surveillance, including assessments of seriousness expectedness, causality, coding using MedDRA terminology, evaluation for evidence of a potential safety signal, and assessment of the requirements for expedited reporting
Contribute to development of protocol specific safety definitions, in collaboration with mult-idepartmental clinical trial team members, such as clinical medical leads, nonclinical experts, translational medicine experts, and engineers to define data acquisition strategy, methodology, and approach for safety evaluations
Serve as drug safety representative on clinical trials with CRO participation
Lead or contribute to assigned Safety Management Teams
Advise on safety concerns
Contribute to regulatory responses to safety questions
Work closely with clinical teams and other relevant stake holders to interpret safety regulations, develop presentations, and applicable regulatory documents that address the PV System
Track metrics and oversee timelines for PV deliverables such as the percentage of cases submitted on time and periodic report requirements.
Responsible for effective execution, communication, and influence with internal stakeholders (e.g., clinical development, medical, regulatory) and external stakeholders (e.g. FDA, other regulatory agencies, and license partners, as applicable)
Stays abreast of current and emerging trends on PV/safety regulations and guidance from the regulatory authorities, SOPs and quality standards, latest scientific literature related to drug safety and emerging safety concerns
Qualification:
BA degree or above in a health care specialty, biological science, pharmacology or public health is preferred
Minimum 3 years of Drug Safety/Pharmacovigilance experience
Excellent knowledge of drug development processes
Good understanding of 21 CFR 314.80 and 21 CFR 312, MA Guideline on good pharmacovigilance practices (GVP) Modules I - X, Good Clinical Practice (GCP, ICH E6), ICH E2A, ICH E2C, ICH E2F and other regional and local regulatory PV requirements and important guidelines for the clients’ products
Experience organizing and leading the PV portion of inspections/audits, and exposure to working relationships with the FDA, EMA and other regulatory authorities is required
Organized, independent, self-motivated, and demonstrated ability to work effectively in an advanced matrix structure
Entrepreneurial vision: demonstrate collaborative spirit, understanding the benefit of working with others cross functionally, in a dynamic environment
Requirements:
Start: asap
Duration: 3 months +
Capacity: 5 days per week
Location: greater Cologne + remote
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