Associate Director, Pharmacovigilance

Rhythm Pharmaceuticals Inc.; Boston (MA); Hybrid; USD 160,000 - 240,000; Full time

Benefits offered by this job

Annual discretionary bonus

Benefits and stock options

Job summary

Rhythm Pharmaceuticals Inc. is seeking an experienced pharmacovigilance professional to support operational activities and ensure high-quality safety data management. The ideal candidate will have over 8 years of experience in pharmacovigilance operations and expertise in global compliance requirements.

This role operates in a hybrid model and is based in Boston, Massachusetts. The expected salary range is $160,000 - $240,000, with potential bonuses based on performance.

Qualifications

• Bachelor’s degree in a relevant healthcare field.
• 8+ years of experience in pharmacovigilance operations.
• Expert knowledge of global PV requirements and practices.

Responsibilities

• Support PV operational activities and ensure high-quality safety data.
• Manage individual case safety reports from clinical trials.
• Contribute to global PV documents preparation and adherence.

Skills

Pharmacovigilance (PV) operations

Regulatory requirements

Communication skills

Vendor oversight

Data review

Education

Bachelor’s degree in Medicine, Pharmacy, Nursing, or equivalent

Tools

Safety databases (e.g. Argus)

Job description

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.

Location and Compensation

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid‑work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel. The expected salary range for this position is $160,000 - $240,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job‑related factors permitted by law. 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.

Equal Employment Opportunity

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.