Medical Director, Oncology, Global Patient Safety

Responsible for supporting the Product Safety Lead (PST) in ensuring safety in one or more products through surveillance, signal detection, validation and assessment. Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

Responsibilities

• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Safety surveillance for pharmaceutical / biological / drug device combined products
• Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
• Under the guidance of PST Lead write, review and provide input on technical documents

Qualifications

• MD / DO with 2+ years of residency with patient management experience required
• Master Public Health is preferred in addition to MD / DO
• Effectively analyze clinical data and epidemiological information required
• Effectively write technical documents with direction
• Work collaboratively in a team environment and be self-starting and able to work independently
• Ability to effectively present recommendation / opinions in group environment
• Fluency, both written and oral, in English

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.