Senior Project Manager, Post-Market Safety Evaluation

Senior Project Manager, Post-Market Safety Evaluation

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Job Description

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 scenarios 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 up-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.

Required Qualifications :

• 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.

Preferred Qualifications :

The base pay for this position is $86,700.00 $173,300.00. In specific locations, the pay range may vary from the range posted.