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Job type full-time
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Job title
Pharmacovigilance lead
Job description
Effective tuesday, january 4, 2022, all u.s.-based employees are required to be fully vaccinated against covid as a condition of employment at philips*Employees may request a reasonable accommodation.
If you are a colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon requestYou may contact 888-367-7223, option 5, for assistance.
Montana employees are currently excluded from this requirement at this time.
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovationDriven by the vision of a better tomorrow.
But it’s not just what we do, it’s who we areWe are 80,000, wonderfully unique individuals, with two things in common: an unwavering sense of purpose and a relentless determination to deliver on our customers’ needsIt’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do moreThat’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today philips’ purpose has never been more relevantSo whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
The pharmacovigilance lead will be a core member of the contract management team providing consulting, process design, training and overarching guidance related to the usaid global health supply chain in-country logistics contractYou will be responsible for overseeing standard operating procedures for the distribution of pharmaceuticals being transported to ensure viability upon receipt to host nations and train their key personnel to follow set procedures.
You are responsible for
Maintaining understanding and ensuring compliance with standard operating procedures (sops), work instructions (wis), global drug/biologic/device regulations, good clinical practices (gcps), ich guidelines, good pharmacovigilance practice (gvp) modules, study plans and the drug development process.
Participating in audits/inspections and ensure inspection readiness.
Participating in quality investigations and ensures implementation of corrective and preventive actions.
Reviewing study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed.
Assisting in the development, review, and approval of departmental standard operating procedures (sops)
Reviewing, providing input, and ensuring the execution of the safety management plan/safety reporting plan.
Participating in process development and improvement
Participating in quality investigations and implementation of corrective and preventive actionsAssists with monitoring dspv compliance with regulations, pv agreements and internal sops.
Functioning on support teams for projects in order to support dspv deliverables.
You are a part of
Our teams of professionals work collaboratively together with our customers and internal partners to ensure an outstanding customer experience and to encourage positive clinical outcomesOn this team you’ll benefit from a growing breadth and depth of healthcare products and services portfolio, and be challenged to drive our best-in-class reputation through top customer experience ratingsIn a ‘one team’ culture, you’ll have the support of an intrinsically linked group of multi-disciplinary experts who are driven by a common mission of making the world healthier and more sustainable.
To succeed in this role, you’ll need a customer-first attitude and the following
Advanced degree in pharmacy, medicine, statistics, health management, business management or public health with other relevant discipline and hands on experience in public health programs especially related to health or pharmaceutical information system, medicine management and patient safety
Masters degree preferred
7+ years of relevant experience in areas of pharmaceuticals and/or health technologies management, regulatory systems strengthening related projects, pharmacovigilance.
Demonstrated experience in regulatory affairs, specifically regulatory information system or health information system.
Knowledge of international regulatory and pharmacovigilance guidelines (who, usfda, iso, etc).
Demonstrated experience in developing and implementing regulatory and/or pharmacovigilance systems strengthening interventions obtained from experience working with national regulatory authority, national pharmacovigilance centers, or from pharmaceutical industry preferred.
In depth understanding of design, planning, and functionalities of e-health related tools.
Experience providing technical assistance on management information systems.
Excellent interpersonal skills, sound judgment, communication skills, training experience, and problem solving abilities.
Willingness to travel overnight up to 10% of the time with possible international travel.
Must be in commuting distance to either washington dc or jacksonville, fl
Us work authorization is a precondition of employmentThe company will not consider candidates who require sponsorship for a work-authorized visa.
In return, we offer you
Sharpen your talents with new challenges in our dynamic organizationAs a market-driven company, we’re used to listening to our customers & apply the same thinking to our employees.
If you are looking for a position with a team that is unique, creative, and on the leading edge of technology and latest procedures, this is the team to join.
How we work at philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customersWe are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy wayHybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: there`s a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: choosing where, when and how to work can vary according to task and team schedulesFlexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: the way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
Why should you join philips?
Working at philips is more than a jobIt’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuumOur people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for philips at a personal level, visit the working at philips page on our career website, where you can read stories from our employee blogOnce there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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 workforceIn 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 888-367-7223, option 5, for assistance.
Equal employment and opportunity employer/disabled/veteran
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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 workforceIn 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 888-367-7223, option 5, for assistance.
Equal opportunity employer/disabled/veteran
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