Associate Director, Safety Science

Scorpion Therapeutics; Boston (MA); Hybrid; USD 160,000 - 210,000; Full time

Job summary

Rhythm Pharmaceuticals is seeking a Lead Pharmacovigilance scientist to oversee safety activities across neuroendocrine disease treatments, ensuring high-quality safety data collection, analysis, and reporting in clinical development and post-approval.

The role includes mentoring junior PV staff, governing safety documentation (PBRERs, PSURs, RMPs), signal detection, risk management, and staying current with PV regulations. Hybrid model based in Boston with some travel requirements.

Qualifications

• Bachelor's degree in Medicine, Pharmacy, Nursing, Epidemiology, or related field.
• 8+ years in drug safety/PV, with 3+ years in safety science including signal detection and risk management.
• Comprehensive knowledge of global PV regulations, ICH guidelines, MedDRA, and safety databases.

Responsibilities

• Oversee safety surveillance across neuroendocrine disease therapies.
• Ensure high-quality safety data collection, analysis, and reporting in clinical development and post-approval stages.
• Provide mentorship to junior PV staff and drive PV process improvements.
• Maintain regulatory-compliant safety documentation (e.g., PBRERs, PSURs, RMPs).
• Stay updated on evolving PV regulations and contribute to regulatory submissions.

Skills

Pharmacovigilance

Signal detection

Regulatory compliance

Stakeholder management

Communication

Education

Bachelor's degree in Medicine, Pharmacy, Nursing, Epidemiology, or related field

Tools

MedDRA

Argus

Job description

Role

Lead pharmacovigilance (PV) scientist supporting safety activities across Rhythm's neuroendocrine disease treatments, ensuring high-quality safety data collection, analysis, and reporting in clinical development and post-approval stages.

Responsibilities

oversee safety surveillance, identify and manage safety signals, maintain regulatory-compliant safety documentation (e.g., PBRERs, PSURs, RMPs), contribute to clinical study safety components, and support PV process improvements. Provide mentorship to junior PV staff and stay updated on evolving PV regulations.

Requirements

Bachelor's in Medicine, Pharmacy, Nursing, Epidemiology, or related field; 8+ years in drug safety/PV, with 3+ years in safety science including signal detection and risk management; comprehensive knowledge of global PV regulations, ICH guidelines, MedDRA, and safety databases like Argus; exceptional organization, communication, and stakeholder management skills.

Preferred

Experience with biologics or rare disease therapeutics, and prior engagement in regulatory submissions.

HighValue

PV leadership in early to late-stage neuroendocrine disorder therapies, expertise in signal detection/risk mitigation, global regulatory compliance, and mentoring.

WorkSetup

Hybrid model based in Boston, MA; some travel required.