Global Neuroscience Patient Safety Medical Director

Actox; Chicago (IL); Hybride; USD 110 000 - 170 000; Plein temps

Avantages offerts par ce poste

PTO

Health insurance

401(k)

Long-term incentives

Résumé du poste

AbbVie is seeking a Pharmacovigilance professional to support Product Safety Leads and potentially lead safety activities for one or more neuroscience products. The role involves surveillance, signal detection, regulatory submission support, and risk management in a fast-paced, cross-functional environment.

Applicants should have an MD/DO with residency, plus 2–4 years PV experience, strong data analysis skills, and the ability to work independently and collaboratively with cross-functional

Qualifications

• MD/DO with 2+ years of residency with patient management experience and Master Public Health.
• Health is preferred in addition to MD/DO but not required.
• 2-4 years of Pharmacovigilance experience in the pharmaceutical industry.
• Effectively analyze and guide analysis of clinical data and epidemiological information.
• Effectively present recommendation / opinions in group environment.
• Write, review and provide input on technical documents.
• Self-starting and can work independently.
• Work collaboratively and lead cross-functional teams.

Responsabilités

• Understanding and application of pharmacology, chemistry and non-clinical toxicology to conduct safety surveillance.
• Safety surveillance for neuroscience products in development and post-marketing.
• Contribute to authorship of pharmacovigilance documents (medical safety assessments, regulatory responses, risk management plans).
• Apply regulatory guidance for safety surveillance and PV documents authorship.
• Analyze and interpret aggregate safety data and communicate findings to cross-functional teams.
• Lead the safety strategy for regulatory submissions (INDs, NDAs, MAAs) and PSURs/PADERS.

Connaissances

Pharmacovigilance

Clinical data analysis

Cross-functional collaboration

Medical writing

Formation

MD/DO

Master of Public Health

Description du poste

AbbVie is seeking a Pharmacovigilance professional to support Product Safety Leads and potentially lead safety activities for one or more neuroscience products. The role involves surveillance, signal detection, regulatory submission support, and risk management in a fast-paced, cross-functional environment.

Applicants should have an MD/DO with residency, plus 2–4 years PV experience, strong data analysis skills, and the ability to work independently and collaboratively with cross-functional