Senior Project Manager, Post-Market Safety Evaluation

Abbott•Santa Clara, CA

23d

About The Position

In this role, you will provide technical and strategic expertise at the post-market phase of product life cycles. Reviews/manages Post-Market Surveillance (PMS) Plans, Periodic Safety Update Report (PSUR) and PMS Report and interacts with various cross-functional teams in order to assist in strategy, plans, and project deliverables. Must be able to effectively manage multiple projects and timelines. With minimum supervision, collaborates with medical writers to create and maintain PMS plans, PSURs and PMS Reports for Abbott products. Identifies appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources including literature, clinical data, and medical references. Creates or participates in the PMS Plan/PSUR/PMS Report timelines. Actively manages timelines and project delays/risks, develops scenario’s and recommendations for management. Ensures project expenditures are within budgetary guidelines Facilitates communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, Product Performance Group (PPG), Sales and Marketing, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers. Maintains update-to-date understanding and experience of clinical / PMS data and risk management. Contributes to the development and maintenance of PSUR/PMS Report DOP/SOP and associated documentation, provides input to cross-departmental SOPs and DOPs as needed.

Requirements

Bachelors Degree (± 16 years), In related field., , an equivalent combination of education and work experience
Minimum 4 years, Related work experience with a solid understanding of specified functional area.
Broad knowledge and application of business concepts, procedures and practices.
Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Learns to use professional concepts and company policies and procedures to solve routine problems.
Works on problems of limited scope.
Independent decision making required.

Nice To Haves

Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred.
Minimum of 6+years of related work experience with an understanding of specified functional area, or an equivalent combination of education and work experience. May consider candidates with less experiences.
Knowledge of PMS Plans / PSURs / PMS Report.
Knowledge of CERs and related documents in accordance with MDR 2017/745.
Understanding of regulations, standards and guidelines related to medical devices clinical studies and quality systems, including: MDR 2017/745; MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.
Effective written, verbal and presentation skills in the area of technical/clinical applications.
Familiar with IMDRF terminology/codes and adverse event reporting is preferred
Project management experience is preferred.
Experience in post-market surveillance, risk management, clinical research, or regulatory affairs in medical device or pharmaceuticals industry
Demonstrated ability to identify and adapt to shifting priorities and competing demands.
Highly-developed interpersonal skills, and strong attention to detail.

Responsibilities

Reviews/manages Post-Market Surveillance (PMS) Plans, Periodic Safety Update Report (PSUR) and PMS Report
Effectively manage multiple projects and timelines
Collaborates with medical writers to create and maintain PMS plans, PSURs and PMS Reports for Abbott products
Identifies appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources including literature, clinical data, and medical references
Creates or participates in the PMS Plan/PSUR/PMS Report timelines
Actively manages timelines and project delays/risks, develops scenario’s and recommendations for management
Ensures project expenditures are within budgetary guidelines
Facilitates communication and exchange of documents between stakeholders
Maintains update-to-date understanding and experience of clinical / PMS data and risk management
Contributes to the development and maintenance of PSUR/PMS Report DOP/SOP and associated documentation, provides input to cross-departmental SOPs and DOPs as needed