Senior Director, Pharmacovigilance (PV) Sciences
Keros Therapeutics
August 22, 2026
Remote friendly (Lexington, MA)
United States
Operations
Job Summary
The Senior Director, Pharmacovigilance (PV) Sciences serves as the bridge between scientific strategy and operational drug safety for the company’s early-stage and clinical pipeline. This hybrid, hands-on role is responsible for both strategic safety science and daily PV operations.
Primary Responsibilities
- Serve as the primary liaison with external PV vendors, CROs, and safety database providers; ensure database readiness and compliance with global regulatory guidelines.
- Develop scalable PV systems and processes as the clinical pipeline transitions.
- Establish and maintain inspection readiness for Health Authority audits.
- Lead proactive signal detection, evaluation, and management; author safety signal assessment reports; write/maintain SOPs and provide DSPV and cross-functional training.
- Lead and manage medical safety and risk management projects (planning, tracking, execution); provide vendor oversight for quality of ICSRs, similar case analysis, and aggregate safety reporting.
- Organize and facilitate cross-functional Safety Management Team (SMT) meetings; prepare minutes and track actions.
- Plan, write, and review key periodic and aggregate safety reports.
- Review safety concerns from internal/external stakeholders and develop safety assessment strategies with PV physicians.
- Provide scientific/medical input into clinical documents (Protocols, IBs, ICFs, CSRs) and ad-hoc safety information requests.
- Tailor benefit-risk assessments and risk mitigation for pediatric populations.
- Schedule follow-up meetings and support company causality assessment for SAEs, pregnancy, and special cases.
- Perform QC and data reconciliation between Clinical and Safety Databases.
- Provide strategic safety contributions to regulatory submissions (INDs; eventual NDAs/BLAs).
Qualifications
- Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 8–10+ years of pharmaceutical industry experience in drug safety/pharmacovigilance as a Safety Scientist (clinical trial and post-marketing).
- Experience authoring safety signal assessment reports; DSUR, PBRER, RMP, and RSI.
- Knowledge of drug development, pharmacovigilance databases, and MedDRA coding.
- Excellent written/verbal communication and presentation skills.
- Flexible, able to adapt and work independently; strong matrix/collaborative experience.
- Strong time management and ability to prioritize to meet deadlines.
The Senior Director, Pharmacovigilance (PV) Sciences serves as the bridge between scientific strategy and operational drug safety for the company’s early-stage and clinical pipeline. This hybrid, hands-on role is responsible for both strategic safety science and daily PV operations.
Primary Responsibilities
- Serve as the primary liaison with external PV vendors, CROs, and safety database providers; ensure database readiness and compliance with global regulatory guidelines.
- Develop scalable PV systems and processes as the clinical pipeline transitions.
- Establish and maintain inspection readiness for Health Authority audits.
- Lead proactive signal detection, evaluation, and management; author safety signal assessment reports; write/maintain SOPs and provide DSPV and cross-functional training.
- Lead and manage medical safety and risk management projects (planning, tracking, execution); provide vendor oversight for quality of ICSRs, similar case analysis, and aggregate safety reporting.
- Organize and facilitate cross-functional Safety Management Team (SMT) meetings; prepare minutes and track actions.
- Plan, write, and review key periodic and aggregate safety reports.
- Review safety concerns from internal/external stakeholders and develop safety assessment strategies with PV physicians.
- Provide scientific/medical input into clinical documents (Protocols, IBs, ICFs, CSRs) and ad-hoc safety information requests.
- Tailor benefit-risk assessments and risk mitigation for pediatric populations.
- Schedule follow-up meetings and support company causality assessment for SAEs, pregnancy, and special cases.
- Perform QC and data reconciliation between Clinical and Safety Databases.
- Provide strategic safety contributions to regulatory submissions (INDs; eventual NDAs/BLAs).
Qualifications
- Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 8–10+ years of pharmaceutical industry experience in drug safety/pharmacovigilance as a Safety Scientist (clinical trial and post-marketing).
- Experience authoring safety signal assessment reports; DSUR, PBRER, RMP, and RSI.
- Knowledge of drug development, pharmacovigilance databases, and MedDRA coding.
- Excellent written/verbal communication and presentation skills.
- Flexible, able to adapt and work independently; strong matrix/collaborative experience.
- Strong time management and ability to prioritize to meet deadlines.