Associate Director, Pharmacovigilance

Responsibilities and Duties

• Responsible for supporting all PV operational activities across Rhythm products in clinical development and post approval stages ensuring the delivery of high-quality safety data.
• Oversee day-to-day individual case safety reports management from clinical trials and post-marketed sources in accordance with PV procedures, regulatory requirements and timelines that are supported by Rhythm PV vendors.
• Actively involved in PV vendor(s) management through daily emails, monitoring Key Performance Indicators (KPIs) and metrics, periodic governance meetings, and implementation of effective Corrective and Preventative Action plans, as applicable.
• Contribute to planning and preparation of key global PV documents, including but not limited to Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Safety Update Report (PSUR), Development Safety Update Reports (DSURs), and Risk management Plans (RMPs).
• Act as a PV Lead for the assigned clinical studies and support cross-functional teams’ deliverables, as applicable.
• Provide input to clinical study documents, including protocols, Investigators Brochures, clinical study reports, regulatory documents/responses, and safety management plans.
• Actively participate in PV team strategic planning, process improvement, audits and PV work instructions and standard operating procedures development.
• Support, train, mentor Rhythm PV junior staff and/or Rhythm’s vendors, as needed.
• Stay abreast of evolving PV regulatory landscape and industry best practices to ensure ongoing compliance and operational excellence.

Qualifications and Skills

• Bachelor's degree in Medicine, Pharmacy, Nursing, Epidemiology, Biomedical Sciences, or equivalent healthcare degree.
• 8+ years of PV operations experience is required.
• 3+ years of PV operations experience in a global post-marketing setting preferred.
• Expert knowledge of global PV requirements, Good Pharmacovigilance Practices, ICH Guidelines, MedDRA and proprietary safety databases (e.g. Argus).
• Strong experience in PV processes for vendor oversight, individual case management, aggregate data review, aggregate reports, and audits/inspections.
• Ability to navigate in a matrixed environment, motivate and influence others, and effectively interact with critical internal and external stakeholders.
• Proficiency in English both written and spoken, and excellent written and verbal communication skills with the ability to interact across multiple functions worldwide.