Patient Safety Surveillance Product Manager AstraZenecaLocation: Wilmington, Delaware, United States
Job reference: R-014835
Posted date: Oct. 02, 2017
The Product Manager (PM), US Medical Affairs Patient Safety Surveillance (US PSS) will promote the safety of patients who receive AstraZeneca products, with the aim of optimizing overall benefit/risk with a focus on the US market. The PM reports to the Director of US PSS. Under the leadship of the Director, US Patient Safety (PS) Physician and Team Leader in assigned therapeutic areas, the PM is responsible for PSS activities within the US Marketing Company (MC) including the following 3 Major US PSS Activity Categories: (1) safety surviellance support to actvities related to US MC sponsored clinical studies, (2) Post marketing safety surveillance – focusing on US and (3) safety scientific support to assigned activities related to US Medical Affairs and US Business. Further details of the US PSS activities are described in the ‘Principal Responsibilities’ section below.
The PM does not have any direct reports. The PM will collaborate closely with the Team Leaders on a daily basis in order to support the safety surveillance activities.
- Assist the Team Leader to provide safety surveillance support for actvities related to US MC sponsored clinical studies (CT, NIS, HEOR, PASS, registry, Pharmacoepidemiology, etc).
- Assist the Team Leader to provide safety support for Global sponsored US clinical studies and related projects when delegated by Global PS
- Assist the Team Leader to assist US PS Physician to provide safety support for US managed externally sponsored research (ESR), e.g., IISR.
- Responsible for US specific post marketing safety signal detection, review, management, and documentation with focus on the following activities:
- medication error and lack of efficacy aggregate review
- product quality complaint AE aggregate review
- Assist the Team Leader by providing data support in preparation for US Medical Information Request and US customer insight/trends routine review from Veeva (MSLs) and GMIP (MI)
- Assist the Team Leader by providing data support to Team Leader in preparation for US safety issue management, response to FDA’s safety inquires, and Global RMP development by providing US perspective and US specific safety information
- Assist the Team Leader by providing data support for US specific periodic safety reporting, including production of PADERs
- Assist in risk communication material development by providing data support to the Team Leader and US Physician
Minimum Requirements and Preferred Background
- Training in a medical field (ie, physician, pharmacist, nurse) or life sciences graduate, with proven competence in PS and the relevant areas of clinical development
- At least 3 years Patient Safety experience
- Ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
- Excellent communication, organizational, and interpersonal skills
- Proven professional skills