Global Safety Officer, I&I

Scorpion Therapeutics; Morristown (NJ); On-site; USD 150,000 - 220,000; Full time

Benefits offered by this job

Health benefits

Parental leave

Job summary

Scorpion Therapeutics in Morristown, NJ seeks an experienced pharmacovigilance leader to provide expert safety input across development programs. You will guide risk management, signal detection, and safety reporting, collaborating with SMTs, external partners, and health authorities.

The role requires an MD or equivalent, 3+ years in international PV, and fluent English. You will lead safety reviews, author key safety documents, and support regulatory interactions in a fast-paced environment.

Qualifications

• MD or equivalent medical degree required.
• 3+ years international pharmacovigilance experience; strong clinical judgment.
• Fluency in English, written and spoken.

Responsibilities

• Provide PV and risk management expertise to internal and external customers; act as product safety expert
• Maintain knowledge of product, product environment, and recent literature; stay current on international safety regulations and guidelines
• Lead cross-functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs)
• Communicate and represent PV position within project/product teams and with external partners, key opinion leaders, and Health Authorities
• Provide strategic and proactive safety input into development plans
• Support due diligence activities and pharmacovigilance agreements
• Review/prepare/contribute to/approve clinical development documents (e.g., plans, SAPs, protocols, investigator brochures, data monitoring plans, study reports, safety summaries, and labeling)
• Review/prepare/contribute to responses to questions from health authorities, ethics committees/IRBs, and external partners
• Manage product safety alerts; ensure GPE position is understood by customers; establish credibility of GSO/GPE
• Responsible for signal detection and analysis; collaborate with CoE for signal detection/data mining and safety epidemiology
• Implement proactive safety analysis strategies; lead aggregate safety data review and coordinate safety surveillance
• Provide proactive risk assessment; co-lead benefit-risk assessments
• Develop and monitor risk management strategies/plans; collaborate with CoE for risk management and safety epidemiology
• Represent safety position in cross-functional submission teams; ensure quality of safety sections
• Write/author responses to health authority questions; support Advisory Committee meetings
• Document/coordinate/review/validate periodic reports (e.g., RMP updates and periodic safety updates)
• Serve as medical safety expert to the GPE Periodic Reports group for assigned projects/products

Skills

Clinical judgment

Fluent English

Leadership

Cross-functional collaboration

Communication

Education

MD or equivalent

Board Certified/Board eligible

Job description

Main Responsibilities

• Provide PV and risk management expertise to internal and external customers; act as product safety expert
• Maintain knowledge of product, product environment, and recent literature; stay current on international safety regulations and guidelines
• Lead cross-functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs)
• Communicate and represent PV position within project/product teams and with external partners, key opinion leaders, and Health Authorities
• Provide strategic and proactive safety input into development plans
• Support due diligence activities and pharmacovigilance agreements

Impact

• Perform ongoing assessment of product safety status
• Review/prepare/contribute to/approve clinical development documents (e.g., plans, SAPs, protocols, investigator brochures, data monitoring plans, study reports, safety summaries, and labeling)
• Review/prepare/contribute to responses to questions from health authorities, ethics committees/IRBs, and external partners
• Manage product safety alerts; ensure GPE position is understood by customers; establish credibility of GSO/GPE

Signal Detection and Assessment

• Responsible for signal detection and analysis; collaborate with CoE for signal detection/data mining and safety epidemiology
• Implement proactive safety analysis strategies; lead aggregate safety data review and coordinate safety surveillance

Risk Assessment/Risk Management/Benefit-Risk Assessment

• Provide proactive risk assessment; co-lead benefit-risk assessments
• Develop and monitor risk management strategies/plans; collaborate with CoE for risk management and safety epidemiology

Submission Activities

• Represent safety position in cross-functional submission teams; ensure quality of safety sections
• Write/author responses to health authority questions; support Advisory Committee meetings

Report Writing

• Document/coordinate/review/validate periodic reports (e.g., RMP updates and periodic safety updates)
• Serve as medical safety expert to the GPE Periodic Reports group for assigned projects/products

Knowledge and Skills

• Excellent clinical judgment; ability to synthesize/critically analyze multi-source data
• Communicate complex clinical issues orally and in writing; develop and document sound risk assessment
• Initiative and ability to work under pressure; leadership in cross-functional teams; strong teamwork/interpersonal skills
• Fluent in English (written and spoken)

Formal Education and Experience Required

• M.D. or equivalent
• Board Certified/Board eligible (preferred)
• Minimum 3 years total experience in international pharmacovigilance (or equivalent relevant industry experience with clinical experience considered); exceptional candidates may be considered with less than 3 years international PV experience

Benefits

• Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave