Vigilance Specialist

Job Description

Come join our team of professionals who are on the frontline of investigating global product performance, assuring Agilent's products are safe and effective for both users and patients!

Job Profile Summary:

Responsible for the global adverse event reporting for all product lines within Agilent. Designs and develops product safety procedures and monitoring strategies to ensure compliance with national and international regulations and regulatory agency requirements. Creates programs and processes to respond to audits and safety inspections, as well as deliver reports to Agilent management and external regulatory agencies. Participates in IVDR deliverables and gap analysis. Accountable for oversight of safety in clinical trials and post marketing programs. Develops and delivers training programs to educate the organization on medical and vigilance topics, including the definition of a complaint, what makes an event reportable, and the requirements for timeliness when aware of a complaint.

In this position you will be responsible for:

• Reporting of MedWatch, MIR, MDPR, and other regulatory forms as required

• Ensure product concerns are investigated to determine if vigilance reporting is required

• Supporting local and regional vigilance activities as requested and determined by the Vigilance team manager

• Assisting the complaints team on a as needed basis including but not limited to investigational guidance, complaint processing, and quality assessments

• Supporting daily operation in terms of vigilance evaluations, escalations of NCRs and product investigation raised locally

• Ad hoc participation in CAPA activities related to vigilance and complaints

Your primary tasks – Issue evaluation

• Provide daily support of potential cases that need to be evaluated and escalated for Vigilance reporting

• Manage assigned complaints/events and conduct vigilance investigations collecting information to assist in the analysis of case reportability to regulatory authorities

• Provide feedback regarding necessary updates to risk assessment documentation and support as required

• Prepare data and research for input into metrics, trending, risk assessments, health hazard assessments

• Participate in complaint, vigilance, quality (CAPA), and regulatory meetings providing support as needed

• Proactively engage with cross-functional team members during investigations including, but not limited to, members from R&D, Regulatory, Clinical, Manufacturing, Technical support, Logistics and Field teams

Additional tasks in Vigilance Team

• Process improvements projects

• Prepare local activities supporting product investigations and vigilance documentation in accordance with procedures and regulatory requirements

• Lead and assist in organizing and facilitating cross-departmental training sessions focused on identifying and managing potentially reportable events

• Develop and update vigilance-related SOPs conducting a comprehensive assessment of current processes, identifying areas for improvement, and ensuring compliance with regulatory requirements

• Support post market surveillance

You will be communicating both internally and externally:

Internal:

• Communicate with the broader Agilent organization as appropriate in relation to activities related to the job function

• Close communication with vigilance and complaint team members – to align cases

External:

• Communication with subject matter experts (SME’s) in other organizations

• Communication with FDA and other regulatory authorities as needed

Qualifications

Your profile:

• Preferably M.Sc. or B.Sc. degree in a scientific or technical discipline or other relevant technical education

• 4+ years of experience

• Experience with vigilance documentation/activities relating to Medical Device Reporting

• Ability to interpret regulatory standards, guidance, and laws

• Strong written and oral communication skills (in English) to a global organization including contact to distributors

• Thoroughly versed in Quality System Standards e.g. ISO 13485, FDA CFR 21 Part 803, 806 and 820 and similar global regulations, including preferably IVD/Medical Device legislation in the USA (MDR) and EU (MEDDEV)

• Track record of applying good judgement in determining if reported issues and complaints are reportable based on IVD/Medical Devices or similar legislation

• Skilled in effectively and efficiently documenting events and findings

• Experience with data analysis, troubleshooting, problem solving in compliance with the regulation and presentation of results

• Demonstrate ability to collaborate across different functions

• Preferably antibody, probe production and QC knowledge (IHC, ISH), knowledge of instrumentation used for IHC and ISH tests.

• Result oriented, proactive, ambitious, flexible and creative

• Capable of working independently, however at the same time active in teamwork

We offer:

• Training and development opportunities

• A commitment to work/life balance

• A company with values around innovation and contribution, uncompromising integrity, trust, respect and teamwork, speed, focus, and accountability

• The diversity of cultural and individual perspectives held by our employees and their commitment to inclusion

• You will be reporting directly to the Vigilance Team manager which is situated in US.

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Additional Details

This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least December 12, 2024 or until the job is no longer posted.

The full-time equivalent pay range for this position is $103,200.00 - $193,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required:

Occasional

Shift:

Day

Duration:

No End Date

Job Function:

Medical/Clinical