Associate Director, Pharmacovigilance

Rhythm Pharmaceuticals • Boston, MA

6d • $160,000 - $240,000 • Hybrid

About The Position

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. This role is 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. The Associate Director will 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. They will be 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. The role also contributes to planning and preparation of key global PV documents, acts as a PV Lead for assigned clinical studies, and provides input to clinical study documents. Additionally, the Associate Director will participate in PV team strategic planning, process improvement, audits, and the development of PV work instructions and standard operating procedures. They will also support and train junior staff and/or vendors, and stay abreast of evolving PV regulatory landscape and industry best practices.

Requirements

• Bachelor's degree in Medicine, Pharmacy, Nursing, Epidemiology, Biomedical Sciences, or equivalent healthcare degree.
• 8+ years of PV operations experience is required.
• 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.

Nice To Haves

• 3+ years of PV operations experience in a global post-marketing setting preferred.

Responsibilities

• Supporting all PV operational activities across Rhythm products in clinical development and post approval stages ensuring the delivery of high-quality safety data.
• Overseeing 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.
• Contributing to planning and preparation of key global PV documents, including but not limited to Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Safety Update Report (PSURs), Development Safety Update Reports (DSURs), and Risk management Plans (RMPs).
• Acting as a PV Lead for the assigned clinical studies and supporting cross-functional teams’ deliverables, as applicable.
• Providing input to clinical study documents, including protocols, Investigators Brochures, clinical study reports, regulatory documents/responses, and safety management plans.
• Actively participating in PV team strategic planning, process improvement, audits and PV work instructions and standard operating procedures development.
• Supporting, training, and mentoring Rhythm PV junior staff and/or Rhythm’s vendors, as needed.
• Staying abreast of evolving PV regulatory landscape and industry best practices to ensure ongoing compliance and operational excellence.

Benefits

• A discretionary annual bonus may be available based on individual and company performance.
• This role may be eligible for benefits and other compensation such as restricted stock units.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager