Local Safety Officer

6 meses atrás

Lisboa, Portugal Fortrea Tempo inteiro

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Primary responsibility

Cross Sector IPV Case Management Specialist is to:

- Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.
- The role holder may be expected to support and ensure case management and related activities for other countries within the EMEA Region (centralized case management) are carried out in a timely manner.

As applicable, the responsibilities described below may account for cross-country collaborations

INBOUND & OUTBOUND ICSR CASE MANAGEMENT- Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.- Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.- Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.- Data entry for complex cases- Performing follow-up for requesting additional information from multiple sources.- Assist in the quality review of data captured in the GIRS as applicable- Verify and ensure translation of safety information, if applicable.- Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.- Enable mechanisms to support LSO oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner.- Liaise with applicable stakeholder to support case processing requirements for Medical device vigilance, and/or cosmetovigilance (as applicable).

AGGREGATE REPORTING- Ensure timely submission of aggregate safety reports (e.g. DSUR, PSUR etc. applicable) to applicable health authorities, in collaboration with local medical safety input (as applicable).

COMPLIANCE MONITORING- Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable.- Support LSO in review of new/revised PV regulations, evaluation of the impact on local processes and notification of appropriate global and regional

AUDIT / INSPECTION PREPARATION AND SUPPORT- Represent IPV Case management or support the LSO, in matters pertaining to audit or inspection preparation or conduct.

Education, Skills and Other Requirements:

- minimum 3-4 years of relevant pv experience.

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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