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Area/Local Safety Officer Consultant

ClinChoice is a global full-service CRO seeking a confident Area/Local Safety Officer Consultant with expertise in pharmacovigilance and data management for a hybrid 12-month contract role.

Skills

  • Data Management
  • Regulatory Compliance
  • Communication Skills
  • Quality Control

Responsibilities

  • Ensure compliance with local regulations and company policies/procedures.
  • Perform quality checks of PV cases.
  • Maintain local trackers of individual safety reports.
  • Oversee training for local employees and business partners.
  • Perform regulatory monitoring and reporting of safety issues.

Education

  • Health care science professional or equivalent training.

Benefits

  • Career development opportunities.
  • Supportive work culture.
To read the complete job description, please click on the ‘Apply’ button
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CEO of ClinChoice
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John D. Balian
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Average salary estimate

$60000 / YEARLY (est.)
min
max
$50000K
$70000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Area/Local Safety Officer Consultant , ClinChoice

Join ClinChoice as an Area/Local Safety Officer Consultant and experience the best of both worlds! Located in Issy-les-Moulineaux, France, you'll work in a role that offers the security of a global CRO while interacting directly with a single sponsor. In this 12-month contract position, you'll ensure that all local safety activities are compliant with regulations and internal policies. This involves everything from quality checking pharmacovigilance cases to maintaining local compliance indicators and ensuring regulatory timelines are met. Your expertise will guide local employees and business partners in safety reporting, while your leadership will be crucial during local health authority audits. Working with ClinChoice means being part of a collaborative and supportive culture where your contributions directly impact the safety of products in the market. With a flexible work environment, including remote work options, you'll be able to maintain a healthy work-life balance while elevating your career in safety management. If you have strong communication skills and a keen eye for detail, this position invites you to further your professional development and contribute to a healthier, safer world!

Frequently Asked Questions (FAQs) for Area/Local Safety Officer Consultant Role at ClinChoice
What are the main responsibilities of an Area/Local Safety Officer Consultant at ClinChoice?

As an Area/Local Safety Officer Consultant at ClinChoice, your primary responsibilities include managing local pharmacovigilance activities, ensuring compliance with safety reporting timelines, performing quality checks on safety cases, and training local staff. You will also be responsible for maintaining compliance indicators, overseeing relationships with local health authorities, and supporting the Area Safety Lead during audits and inspections.

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What qualifications do I need to apply for the Area/Local Safety Officer Consultant position at ClinChoice?

To apply for the Area/Local Safety Officer Consultant position at ClinChoice, you should possess a healthcare science background or equivalent training, along with 2-4 years of relevant experience in case management and vigilance activities. Fluency in English and a mother-tongue proficiency in French are also required, along with strong communication and IT skills.

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Is remote work available for the Area/Local Safety Officer Consultant role at ClinChoice?

Yes, ClinChoice offers a flexible work environment for the Area/Local Safety Officer Consultant role, allowing you to work from home for a portion of the week. The expectation is that you will work from the office in Issy-les-Moulineaux at least two days per week, providing a balance between in-person collaboration and remote flexibility.

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How does ClinChoice support the professional development of Area/Local Safety Officer Consultants?

At ClinChoice, professional development is a core value. As an Area/Local Safety Officer Consultant, you will have access to ongoing training and resources designed to enhance your skills and knowledge. The company invests heavily in the continuous training of its employees to ensure they are equipped to meet both internal and client needs effectively.

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What role does the Area Safety Officer Consultant play in handling audits at ClinChoice?

In the role of Area Safety Officer Consultant at ClinChoice, you will support local health authority inspections and audits by responding to queries and collaborating with the global team to implement CAPA plans as necessary. Your attention to detail and compliance knowledge are crucial in ensuring readiness for these important evaluations.

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Common Interview Questions for Area/Local Safety Officer Consultant
Can you describe your experience with pharmacovigilance processes?

When asked about your experience with pharmacovigilance processes, focus on specific examples where you've been responsible for safety report management, compliance with regulatory submissions, and how you've contributed to improving these processes within your previous roles.

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How do you ensure accurate quality checks of pharmacovigilance cases?

To answer this question effectively, you should explain your systematic approach to quality checks, such as utilizing checklists, double-checking translations, and ensuring compliance with timelines, along with any tools you use to streamline this process.

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What steps do you take to stay current with local regulatory requirements?

Discuss your proactive methods for staying updated on local regulations, such as subscribing to industry newsletters, participating in relevant training, and networking with other professionals in the field to share insights and updates.

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Can you provide an example of how you managed a compliance issue in a previous role?

Provide a specific instance where you identified a compliance issue, detailing the steps you took to address it effectively, how you communicated with stakeholders, and what measures you implemented to ensure compliance moving forward.

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How do you handle conflicting priorities when managing multiple safety reports?

Discuss your time management skills and prioritize tasks by explaining how you assess the urgency and importance of each report while ensuring that all deadlines are met. Emphasizing your organizational skills can be beneficial in this context.

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What training or mentoring experience do you have in relation to pharmacovigilance?

Talk about your experiences in training or mentoring colleagues in pharmacovigilance processes, including how you tailored your approach to improve their understanding and performance in safety reporting.

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Describe a time when you had to collaborate with cross-functional teams.

Use the STAR (Situation, Task, Action, Result) method to describe how you collaborated with teams such as data management, regulatory affairs, or clinical operations to achieve a common goal related to safety reporting or audit readiness.

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How do you prioritize and manage safety reports when facing tight deadlines?

Emphasize your organizational strategies when managing safety reports under tight deadlines, perhaps by discussing your use of tracking tools or prioritization techniques to ensure that high-impact reports receive immediate attention.

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What experience do you have with regulatory submissions?

Detail your hands-on experience with submitting pharmacovigilance reports to health authorities, including your knowledge of timelines, required documents, and any challenges you've faced along the way that you've successfully navigated.

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Why do you want to work as an Area/Local Safety Officer Consultant at ClinChoice?

Express your alignment with ClinChoice’s mission and values, highlighting the aspects of the role that excite you, such as the focus on quality, the opportunity for professional development, and the chance to contribute to a safer world through your expertise.

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Our mission is to be a valuable partner to our clients by providing a wide variety of services for product development and regulatory submissions. We continuously strive to raise the standard of excellence through accuracy and efficiency. This re...

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SALARY RANGE
$50,000/yr - $70,000/yr
EMPLOYMENT TYPE
Contract, hybrid
DATE POSTED
December 4, 2024

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