Local Safety Officer 263

ProductLife Group is looking for a Local Safety Officer in Brazil to join our dynamic team to contribute to the activities performed in the Hub.

• Act as a Local Safety Officer on behalf of PLG clients in a Brazil
• Ensure the continuity of service for the activities inherent to the vigilance responsibilities delegated to PLG
• Responsible for keeping up to date with local regulatory requirements
• To communicate with local authorities and PLG clients professionally and according to given timelines
• Creation and/or Maintenance of local PSMF (as required)
• Support of local PV system, including creation of a local SOPs and agreements Review / update Safety Data Exchange Agreement (SDEA) / Pharmacovigilance Agreement (PVA) / Technical Agreement (TA) as required
• Support/Contribute to local pharmacovigilance (PV) activities performed by the pharmacovigilance /Medical Information line of business in local country
• Liaise with client, affiliate departments and other 3rd party vendors
• To comply with client and PLG policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives
• Contribute/support to the production of client administrative documents, reports and tracking tools
• To participate in audits / inspections and resulting action plan
• Ensure confidentiality and data protection rules are followed, as applicable

Safety information and Medical Information management:

• To perform safety case receipt, processing, translation, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients in Brazil, in accordance with agreed timelines, as required
• Perform Local ICSR submissions to local regulatory authorities in Brazil according to local legislation
• To carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG Clients
• Provision or support of local medical information services (as required)

Local literature and regulatory website monitoring

• Monitoring of Local literature/journal(s) for PLG’s clients products in Brazil (as required)
• Perform QC and track activity and results from the literature monitoring
• Assist in selection and review of local journal list when required
• To monitor local Braziln authority websites for changes in national legislation or safety information relevant for PLG clients
• Tracking of regulatory authority screening and providing results to relevant PLG clients

Other responsibilities (optional):

• Support/oversight of local studies and risk minimisation measures/ activity.
• To perform DSUR, PSUR and RMP translation and submission, as required
• Provision of training to PV stakeholders (sales rep, distributors, affiliate), as required

• Bachelor’s or Master’s degrees (according to the country and the experience) in Medicine, Pharmacy, nursing, or science related field, or equivalent experience
• 2+ years’ experience in pharmacovigilance
• Excellent knowledge of local Brazil and international regulations
• Experience in local PV case management, including receipt, translation, submission and follow up is essential
• Experience in acting as a local contact person in Brazil is desirable
• Experience in local literature and regulatory website screening is desirable
• Previous experience performing local pharmacovigilance activities in Brazil for a European company is desirable
• Experience of safety database/MedDRA is desirable