Associate Director, Pharmacovigilance

Scorpion Therapeutics; Boston (MA); Hybrid; USD 160,000 - 240,000; Full time

Benefits offered by this job

Hybrid work model

Bonus potential

Job summary

Rhythm Therapeutics in Boston is seeking a Pharmacovigilance Lead to oversee PV operations across clinical development and post‑marketing products, ensuring high‑quality safety data management.

Responsibilities include managing individual case safety reports, vendor governance, and contributing to global PV documents (PBRERs, PSURs, DSURs, RMPs), mentoring junior PV staff, staying current with PV regulations, and supporting cross‑functional safety deliverables.

Qualifications

• Bachelor's degree in Medicine, Pharmacy, Nursing, Epidemiology, or Biomedical Sciences.
• 8+ years PV operations experience, with 3+ years in global post-marketing.
• Strong knowledge of global PV requirements, GxP, ICH guidelines, MedDRA.
• Excellent English communication and stakeholder interaction.

Responsibilities

• Oversee PV operations across clinical development and post-marketing products.
• Manage individual case safety reports from trials and external sources.
• Vendor oversight through KPI monitoring and governance.
• Contribute to global PV documents: PBRERs, PSURs, DSURs, RMPs.
• Support cross-functional safety deliverables and input for study documents.
• Participate in PV strategic planning, audits, and SOP development.
• Mentor junior PV staff and stay updated on PV regulations.

Skills

PV operations

Global post-marketing safety

Stakeholder management

Quality data management

Mentoring / coaching

Education

Bachelor's degree in Medicine, Pharmacy, Nursing, Epidemiology, or Biomedical Sciences

Tools

Argus

MedDRA

Job description

Pharmacovigilance (PV) Lead responsible for overseeing PV operations across Rhythm's clinical development and post-marketing products, ensuring high-quality safety data management.

Responsibilities include managing individual case safety reports from trials and post-marketing sources, vendor oversight through KPI monitoring and governance, and contributing to global PV documents such as PBRERs, PSURs, DSURs, and RMPs. The role supports cross-functional safety deliverables, provides input for clinical study documents, and participates in PV strategic planning, process improvements, audits, and SOP development. It also involves mentoring junior PV staff and staying current with evolving PV regulations and industry best practices.

Qualifications include a Bachelor's degree in Medicine, Pharmacy, Nursing, Epidemiology, or Biomedical Sciences; 8+ years of PV operations experience, with 3+ years in a global post-marketing setting preferred. Expertise in global PV requirements, GxP, ICH guidelines, MedDRA, and safety databases like Argus is essential. Strong stakeholder interaction skills within matrix environments and excellent communication in English are required.

The position is based in Boston, operating under a hybrid-work model, with some travel expected. The role offers a salary range of $160,000-$240,000, with potential bonuses and benefits. The focus is on supporting Rhythm’s mission to develop medicines for rare neuroendocrine diseases, emphasizing regulatory compliance, safety monitoring, and cross-functional collaboration in a global, innovative environment.