Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

*MUST BE BASED IN BRAZIL AND FLUENT IN ENGLISH*

The Senior Pharmacovigilance (PV) Specialist, Regulatory Intelligence (RI) and Submissions is responsible for adverse event submission and tracking of adverse event reports and periodic reports, maintenance of adverse event submission and exchange compliance, testing for health authority submission, process testing for submitting adverse event cases to new territories and/or for new product types, assigned safety reporting regulations research and assisting with PV regulatory intelligence queries, monthly PV regulatory searches, impact assessment, xEVMPD submissions and ad hoc projects.

- Adverse Event Submission and Safety Partner Exchange Compliance:

• Adheres to ProPharma’s processes and instructions associated with pharmacovigilance regulatory reporting, including daily monitoring of scheduled expedited and non-expedited individual case safety report (ICSR) submissions and exchanges.
• Execution of monthly ICSR reconciliation reports with PV clients and their safety partners.
• Assists in testing gateway-to-gateway submissions to health authorities and ICSR exchange with their safety partners.
• Assists with creation and closeout of all submissions-related deviations and associated CAPAs.

- Periodic Reports:

• Generates multi-tenant Argus-based line listings and summary tabulations for Periodic Safety Reports.
• Assists with the generation and verification of custom reports for periodic reporting.
• Assists in the setup and verification of Periodic Safety Report requirements to health authorities.
• Assists the pharmacovigilance management team in coordinating, developing, and maintaining all aspects of ProPharma’s pharmacovigilance reporting services.
• Submits periodic reports according to local regulations.

- Safety Regulatory Intelligence:

• Collection and review of PV reporting requirements for ProPharma’s internal use, newsletter, and for contracted services for drugs, biologics and devices as assigned.
• Assistance with PV regulatory intelligence tools, queries, tickets, mailbox and ad hoc requests and projects as assigned.

- Regulatory Intelligence and Submission Projects:

• Fulfills the tester role in performance qualification (PQ) testing for multi-tenant Argus upgrades, patches, and custom projects.
• Executes process and documentation updates associated with new territory specific E2B profiles and custom E2B profiles.
• Fulfills the tester role for Submissions-based PQ testing for data migration imports involving the multi-tenant Argus database.
• Assists the team with various projects to enhance system performance.
• Provides support with regulatory intelligence initiatives and projects.

- Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) Drafting and QC:

• Completes the drafting of XEVMPD updates, removals, new entries within specified timelines
• Completes peer quality review and submission of drafted tasks by other colleagues.
• Completes other XEVMPD tasks such as bulk updates, updates to QPPV or Master file Location, or addition of developmental products.

Necessary Skills and Abilities:

• Proficient computer knowledge, specifically Microsoft Office Suite (Outlook, Word, Excel) and computer keyboarding skills.
• Excellent attention to detail.
• Strong verbal, written and interpersonal communication skills.
• Flexibility to adapt and meet fluctuating business priorities.
• Ability to work independently and collaboratively in a multi-disciplinary team.

Educational Requirements:

• High school diploma required.
• Post-secondary education (life science degree preferred) or equivalent professional work experience in pharmacovigilance safety regulatory submissions or safety regulatory intelligence is preferred.

Experience Requirements:

• Minimum 3 years of experience working in safety databases.