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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.

• 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 departments as applicable.

• Receive and support the Area Safety lead in the responses to safety-related health authority queries in the territory.

• 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.

• 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 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).

Requirements:

• Degree with life science, nursing, pharmacy related studies, or equivalent training and experience

• 1-2 years of relevant experience.

• Pharmaceutical industry experience 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com