O pozici
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for an Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension to join one of our clients.
The Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners .
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Co budeš dělat
- Safety and PV System Management
- Perform the quality check of the PV cases and ensure that the English translation has been properly performed.
- Keep up to date a local tracker of the individual safety reports.
- Be the subject matter expert at local level on the case management activities.
- Closely follow the respect of the regulatory timelines of the submission of the safety reports to the local health authorities and communicate any potential delay to the appropriate teams.
- Establish and maintain local indicators on the compliance of the safety reports submission.
- Oversee the training of the local employees and the business partners. Maintain KPI and present them during regular team meetings.
- Perform regulatory monitoring for impact on vigilance activities and responsibilities.
- Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
- Maintain oversight of proper identification of local literature articles for AE reporting as required.
- Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Client departments as applicable.
- Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals.
- Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.
- Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
- Perform other agreed tasks assigned by manager
- Perform document management and archiving as required
- Procedural Document
- Ensure current knowledge of all relevant company procedures and training.
- Develop, update, and implement local procedures to ensure compliance with Clients global procedures and national requirements.
- Audit & Inspection readiness
Koho hledáme
- Education: health care science professional or equivalent training
- Significant training in data management with strong IT skills.
- 2-4 years of relevant experience (e.g. case data management, reconciliation manager, vigilance IT project manager…).
- Fluent in English. French as a mother tongue.
- Excellent communication skills and ability to work with cross-functional teams.
- Rigor is a key skill for this mission.
Benefity
- ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture.
- Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel.
- The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.
- The success of these core values is evidenced by our below industry average turnover rates.
- ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity.
