Area Safety Lead Consultant

ClinChoice is seeking a Senior Area Safety Officer Consultant for a 12-month contract with possible extension, working directly with a single sponsor while benefiting from a global CRO's resources. This hybrid role, based in Dubai Healthcare City, involves working onsite 3 days a week.The Senior Area Safety Officer will manage local operating company (LOC) safety activities for all products, ensuring compliance with local regulations and company policies at all levels. They will establish product vigilance and risk management systems to oversee products effectively.ClinChoice, a global full-service CRO, emphasizes quality, professional development, and a supportive culture, seeking confident candidates who can work independently and build trust with client counterparts.Responsibilities:

• Oversight of the PV System & Overall responsibilities
• Provide oversight of vendor resources within AMET
• Support the Area Safety Head in providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files.
• Perform other agreed tasks assigned by manager.
• Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective Corrective and Preventative Actions (CAPAs).
• Safety Management & Reporting
• Receive and support the Area Safety Head in the responses to safety-related health authority queries.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for Adverse Event (AE) reporting as required.
• Perform document management and archiving as required.
• Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Collaborate with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.
• Manage reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other departments as applicable.
• Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetovigilance, materiovigilance and nutrivigilance, 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.
• Ensure pharmacovigilance compliance of local company sponsored programs and research activities as applicable.
• Perform translation for ICSR and PV-related documents, as required.
• Provide technical and strategic input and participate in projects/ workstreams led by the Medical Safety teams or LOC
• Develop, update, and implement local procedures to ensure compliance with global procedures and national requirements.
• Ensure current knowledge of all relevant company procedures and training.
• Support 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 plans as applicable.
• Management of PV clauses to be included within local agreements.
• Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).

Requirements:

• Health care science professional e.g.: (Pharmacist, nurse…)
• At minimum 3 years’ experience.
• Pharmaceutical industry experiences including product vigilance responsibility role.
• Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field.
• Proven ability to organize workflow activities.
• Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.
• Knowledge of global, regional, and local procedural documents as applicable.
• Computer literate with knowledge of relevant IT safety systems.
• Good verbal and written communication skills.
• Ability to establish and maintain open relationships within the organization and with authorities.
• Demonstrable knowledge of all local requirements and of global aspects of product safety.
• Fluency in the English language.

The role offers:

• Opportunity to work directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring.
• 12 months Contract with possibility of extension
• Hybrid Model: 3 days a week