Medical Director, Senior Patient Safety Physician
Medical Director, Senior Patient Safety Physician
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$ 233290 - 349935
1 Vacancy
Job Description
As a Medical Director Senior Patient Safety Physician in Patient Safety BioPharma youll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives. BioPharma Global R&D drives our innovative pipeline redefining science into valued new medicines and ensuring patients around the world can access them.
Main Duties and Responsibilities:
In this role youll be responsible for the Clinical Safety strategy for assigned drug projects and products throughout all stages of development and/or when on the market including implementation and communication of the strategy at the project team/governance level. Essentially the continued safety assessment evaluation and risk management of AZ products or product groups in various stages of clinical development and/or the post-marketing setting as well as the continuous efficient evaluation of adverse event and all other safety information will be within the remit and scope of this role.
You will provide consistent communication of safety topics across all regulatory safety documents e.g. Periodic Benefit Risk Evaluation Reports (PBRERs) Periodic Adverse Drug Experience Reports (PADERs) and Development Safety Update Reports (DSURs) for assigned product(s)/program(s).
You will proactively evaluate the clinical implications of safety data from pre-clinical studies clinical studies literature to predict / establish the safety profile of compounds in clinical development. This process includes employing expert groups and methodologies such as Safety Knowledge Groups (SKGs) Safety Science Informatics expertise modeling and simulation to manage the risk to patients. Additionally youll be involved in all safety surveillance activities that may include: medical review of individual safety cases (providing medical expertise and judgment) signal detection evaluation and safety information review committee activities for all products in area of responsibility.
This role will also require your medical input and review of periodic reports (e.g. PBRERs PSURs or DSURs) and renewal documentation submitted to regulatory agencies and the patient safety contribution to global regulatory submissions (NDA BLA MAA etc.) for new products formulations or indications.
Essential Education Experience and Skill Requirements
- Medical degree (e.g. MD MBBS).
- At least 2 years of clinical experience post-registration
- High level of medical competence with an ability to balance this with industry standards to achieve business goals.
- At least 2 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery.
- Ability to work effectively in an advanced matrix structure
- Proficient in written and verbal English
Preferred Education Experience and Skills
- MSc/PhD in scientific field
- Experience managing Patient Safety colleagues
- A demonstrated ability to understand epidemiological data
The annual base pay (or hourly rate of compensation) for this position ranges from $233290 to $349935. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and experience. In addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles)to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
Date Posted
10-Jun-2025Closing Date
16-Jun-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion starting with our recruitment process. We welcome and consider applications from all qualified candidates regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations please complete the section in the application form.Required Experience:
Director
Employment Type
Full-Time
