Area/Local Safety Officer Consultant

at  ClinChoice

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.
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.

EDUCATION AND EXPERIENCE:

• Education: health care science professional e.g.: (nurse, pharmacist, life science degree) or equivalent training and experience.
• 1-2 years of relevant experience.
• Pharmaceutical industry experiences including product vigilance responsibility role.
• Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field.
• Sound knowledge of medical terminology
• Computer literate.
• Good verbal and written communication skills.
• Ability to establish and maintain open relationships within the organization and with authorities.
• Fluency in the national language(s) and the English language.

• Function as nationally nominated person or back up for the local nominated person for Pharmacovigilance in respective countries assuming the PV role as defined by national law if applicable.
• 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 Kenvue departments as applicable.
• Receive and support the Area Safety Head in the responses to safety-related health authority queries in the territory.
• Supporting Area Safety Head 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.
• Perform training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• Perform translation for ICSR and PV-related documents, as required.
• Develop, update, and implement local procedures to ensure compliance with Kenvue global procedures and national requirements.
• Ensure current knowledge of all relevant company procedures and training.
• Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable.
• Provide PV clauses to be included within local agreements.
• Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).