Associate Medical Review Director

Scorpion Therapeutics; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director Medical Review to lead medical evaluation of adverse events and ensure regulatory compliance for safety reporting. This role interfaces with Global Safety and regulatory teams to ensure accurate interpretation and signal detection across post-marketing data.

The successful candidate will hold an MD/DO, have at least 1 year in pharma, and possess MedDRA coding experience, with strong written and spoken English.

Qualifications

• MD/DO with current clinical knowledge and therapeutic area awareness.
• Minimum 1 year of pharmaceutical industry experience.
• Strong written and verbal English proficiency.

Responsibilities

• Liaise with Global Safety and regulatory teams on safety matters.
• Perform medical review and evaluation of adverse events.
• Ensure regulatory status for expedited reporting and signal detection.
• Conduct aggregate review of post-marketing safety data with Global Safety.
• Support training and knowledge updates on FDA/ICH standards.

Skills

Medical review

Safety science

FDA regulatory knowledge

MedDRA coding

Education

MD/DO

Job description

The Position (Associate Director Medical Review)

Responsible for performing medical review and validation of incoming adverse events, ensuring correct medical interpretation (including evaluation of expectedness and reportability). Ensures consistency in evaluation of adverse event cases. Ensures compliance with US drug/device safety reporting regulations, ICH guidelines, and internal procedures for evaluation, reporting, and surveillance of clinical and post-marketing safety information. Contributes to and maintains the company’s product safety profile with HQ.

Essential Functions

• Liaise with Global Safety and NNI medical/clinical/regulatory on safety matters
• Narrative writing, medical evaluation of cases, database reconciliation, protocol review
• Provide medical input in ICSR safety review (post-marketing sources)
• Review individual safety reports: medical content, expectedness/listedness, regulatory status for expedited reporting, and possible signal detection
• Perform aggregate medical review of post-marketing non-serious adverse events with Global Safety
• Handle local aggregate report activities (e.g., PBRERs, PADERs) with safety input
• Guide case processing personnel on seriousness, expectedness/listedness, and causality for FDA reportability; serve as Patient Safety lead SME in PRB meetings
• Determine regulatory submissions for ICSDRs and perform quality checks with case processing teams
• Support internal/external training (e.g., onboarding and annual safety training)
• Maintain up-to-date knowledge of FDA/ICH and industry safety surveillance/reportability standards; perform gap analysis and impact assessment
• Provide Patient Safety input to Local Labeling Committee and review/disseminate affiliate mailbox information

Physical Requirements

• 0–10% overnight travel

Qualifications

• MD/DO required; up-to-date knowledge of clinical/therapeutic principles
• Minimum 1 year pharmaceutical industry experience
• Computer literacy
• Excellent written/verbal English
• MedDRA coding experience required

Application

For accommodation requests only: 1-855-411-5290