Vigilance & Safety Board Post-Market-Surveillance Specialist
Vigilance & Safety Board Post-Market-Surveillance Specialist
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$ 64000 - 119600
1 Vacancy
Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Thats what makes us Roche.
As a Vigilance/Safety Board/Post Market Surveillance Specialist of Post Market Quality you are part of our Global Quality and Regulatory organization. You will be accountable for the timely handling of safety related and/or vigilance cases according to ISO Quality System requirements and regulations and needs of the Country Organizations. In this business critical role you will be responsible for optimizing processes to increase quality and efficiency standards with a focus on customer compliance and continuous improvement.
The Opportunity
You interface with Regulatory Authorities (i.e. FDA BfArM MHRA Notified Bodies Regulatory Agencies). You ensure cases are compliant and conform to established quality processes standards and regulations.
You prepare and coordinate responses to issues escalated by Affiliate Organization and collaborate with the appropriate subject matter experts to obtain the information required for the response. This includes managing affiliate notification feedback including reconciliation and escalation for overdue responses.
You participate in the development and delivery of specific training to ensure a high level of awareness and compliance to internal procedures and regulations related to Safety Board/Vigilance topics.
You may contribute to the creation of regular reports to document on-market product quality and performance escalate critical issues to the responsible Life Cycle Teams and help define proactive measures. You create or collaborate on notifications (Bulletins and communications to affiliates and ultimately customers via the local organizations) and approve notifications received.
You assume responsibility to ensure risk assessments for product quality issues are complete. You are responsible for escalating issues which cannot be directly resolved to appropriate levels and initiate further investigation and communicate case derived information as appropriate.
You may provide audit and inspection support as requested.
Who You Are
You have a Bachelor in Sciences and/or vocational training with related experience.
You have 0-3 years experience working in a regulated environment.
You have experience working in virtual teams and in an intercultural context.
You are fluent in English.
Preferred
You have laboratory experience and/or IT skills.
You have experience in quality systems and vigilance.
Preferred experience in regulatory and vigilance reporting in multiple jurisdictions
A strong sense of quality a confident manner and the ability to focus on solutions.
You are skilled in critical thinking resilience negotiations decision-making with limited information and technical writing skills for authorities (translations).
Locations:
You are based in Indianapolis. We will consider remote work arrangements under extraordinary circumstances.
Relocation benefits are not available for this position.
Please note for this position you will primarily work in EST.
The expected salary range for this position based on the primary location of Indiana is $64000 and $119600. Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.
If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
