Parabilis Medicines

Compensation

Full Description

Job Description: • Oversee all safety reporting activities managed by CROs and consultants, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs). • Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations. • Develop, negotiate, and manage PV sections of contracts, safety management plans, and operational agreements with CROs and consultants. • Monitor CRO performance through KPIs, audits, and oversight activities, ensuring timely and accurate reporting to regulatory authorities, ethics committees, and investigators. • Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, Quality, Legal) to ensure alignment on PV strategy and compliance. • Provide oversight for case processing, medical review, and data reconciliation activities performed by CROs and consultants. • Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness. • Support development and maintenance of internal PV policies, SOPs, and training programs. • Participate in safety signal detection activities and safety governance committees, as needed. • Oversee maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events. • Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations. Requirements: • Master’s degree or higher in a healthcare field. • 10 or more years of pharmacovigilance experience, including at least 5 years in a leadership or oversight role. • Strong experience managing CRO/vendor relationships, particularly in clinical trial safety reporting, including governance oversight. • Deep knowledge of global pharmacovigilance regulations, GVP, ICH guidelines, and relevant reporting requirements. • Experience with oversight of drug safety databases (e.g., Oracle Argus). • Proven track record of ensuring compliance in a global PV environment. Benefits: • an annual target bonus • equity • a comprehensive suite of competitive benefits designed to support our employees’ overall well-being