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Medical Safety Director
3 months ago
Medical Safety Director
Plymouth ,
Minnesota
Apply Now
The Medical Safety Director is responsible for providing medical leadership across all aspects of medical safety throughout product development and life-cycle management.
This role acts across multi-functional teams as a valued individual contributor in providing medical input into all medical safety related activities, with in-depth expertise in processes for safety assessments & surveillance, complaint analysis & benefit-risk assessments.
Your role:
Lead medical safety across various businesses to enable informed patient-centric decisions.
Safeguard patient safety through relevant processes including: Risk Management, Health Hazard Evaluations, Risk-Benefit analyses, recalls, review of post-market surveillance data to evaluate trends, etc.
Provide authoritative medical support to R&D, Clinical Affairs, Regulatory Affairs, Post-Market Surveillance, Quality, Risk Management, Legal & Communications.Contribute to risk management plans and failure mode analysis during product development, safety signal detection and post-market surveillance post-launch.
Participate in clinical safety discussions with KOLs, regulatory agencies / notified bodies, including during regulatory inspections.
Provide input into review of applications for Medical and Scientific Information.
You're the right fit if:
MD, MBChB, MBBS, DO or equivalent with 3+ years direct medical safety experience in medical device/biotech industry
A strong background and deep medical expertise in assessment of clinical risk-benefit throughout product development life-cycle.
Deep knowledge and understanding of all applicable standards / regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc.
Proven ability to be a strong advocate for patient-centric decision making.Anticipating changing priorities and demands and addressing them proactively.
Ability to provide independent, medical input to critically evaluate clinical risk, and make evidence-based risk benefit determinations.
Leading medical input into critical business decisions regarding potential patient safety issues.
Analysis & interpretation of signals & trends from multiple inputs including clinical data, literature, complaints, etc.
You have excellent verbal, written and interpersonal skills required for working effectively in a cross-functional team environment.
Travel up to 25% may be required.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
About PhilipsWe are a health technology company.
We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.
Do the work of your life to help improve the lives of others.Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
Read more about our employee benefits.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply.
You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.The pay range for this position is $154,000 to $295,680 annually.
The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
Details about our benefits can be found here.At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional InformationUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
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It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce.In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact , option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran#J-18808-Ljbffr
