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.
#J-18808-LjbffrAssociate Director, Safety Science in boston at Unknown Company
This position is listed as full time and hybrid.