Analista Senior Farmacovigilancia

Overview

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https : / / www.jnj.com

Job Function

Product Safety

Job Sub Function

Pharmacovigilance

Job Category

Scientific / Technology

All Job Posting Locations

Las Condes, Santiago, Region Metropolitana de Santiago, Chile

Job Description

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https : / / www.jnj.com / innovative-medicine

We are searching for the best talent for Pharmacovigilance Senior Analyst to be in Santiago de Chile.

You Will Be Responsible For

• Reporting
• The Local Safety Officer (LSO) is an employee of the Local Operating Company (LOC).
• The LSO has a direct reporting line into the Cluster Safety Lead for the local Pharmacovigilance (PV) system.
• Primary responsibility
• Be the local regulatory nominated contact for PV before Local Health Authority (LHA).
• Ensure that the LOC PV activities are in compliance with local regulations and company policies / procedures at a local, regional and global level and in accordance with any PV agreements with third party business partners.
• Ensure specified timelines and reporting requirements are met.
• Maintain an appropriate PV and Risk Management system to ensure appropriate oversight for products within its responsibility.
• Delegation
• Components of the Pharmacovigilance Local Operating Company may be delegated, with appropriate documentation.
• The LOC management is the sole responsible party for ensuring that the overall requirements of the Pharmacovigilance Local Operating Company are met. This responsibility cannot be delegated.
• Aggregate reporting
• Plan and ensure timely submission of Aggregate Reports according to local regulations.
• Provide local data as required to support the preparation of Aggregate Safety Summary reports (PSUR, DSUR, etc.).
• Agreements / Contracts containing PV Language
• Perform contract review and maintain oversight to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.
• Coordinate the provision of support for third party safety agreements with PV implications at the local level and ensure the PV agreement is implemented locally, as appropriate.
• Business Continuity
• Create and implement business continuity plans (e.g., inspection readiness, AE reporting and coverage).
• Ensure an effective system is in place for 24-hour coverage.
• Ensure day-to-day PV functions are performed satisfactorily, and regulatory compliance is maintained at the Johnson & Johnson LOC level.
• Case Processing
• Ensure systems and processes are available for collection, review, reporting and reconciliation of Adverse Events (AEs), AE+PQCs, and pregnancy reports from various sources.
• Manage and maintain active involvement in day-to-day AE reporting as applicable.
• Accountable to ensure the LOC meets timelines for safety information management and local regulatory submissions.
• Clinical trial compliance
• Collaborate with Medical Affairs for the review and approval of safety aspects of local study protocols or PSPs to ensure appropriate safety reporting to GMS or applicable case management center and LHA, as required.
• Collaborate & Support
• Collaborate with Regulatory Affairs to forward safety-related inquiries or communications from local HAs to global / regional groups, supporting in New Product Registration / Launch.
• Collaborate with appropriate departments to identify resources needed to address questions, including local, regional and / or global expertise.
• Support QPPV in safety-related regulatory communication when applicable.
• Participate in Product Issue Management teams as appropriate.
• Provide technical and strategic input and participate in projects led by regional PV team and IPV work streams.
• Inspection preparation & support
• Ensure PV inspection readiness at LOC level, manage non-conformances and CAPAs, assist inspectors / auditors, and address follow-up actions.
• Literature search
• Identify local medical / scientific literature not available to GMS, review for AEs and report as required; support literature search strategy.
• New Safety Information
• Ensure new safety information is available to Health Care Professionals in a timely manner, if applicable.
• Other Safety Management & Reporting
• Oversight of case processing activities delegated to the Regional PV Case Management hub or external vendor; includes inbound / outbound reporting, translation, literature search, and follow-up.
• Provide oversight of data generating activities to ensure appropriate AE reporting review and process.
• Ensure vendor contracts include PV language and are archived; support vendor qualification and oversight in PV.
• Safety oversight of clinical projects in the territory as applicable.
• Procedural Document design
• Implement Global and Cross-Pharma Procedural Documents and Local Implementation Memos; verify adherence.
• Documentation storage management
• Risk Management
• Maintain appropriate PV and Risk Management system; participate in Risk Management Plans and Additional Risk Minimization Activities as required.
• Safety Policy / Strategy
• Monitor regulatory changes affecting PV activities and inform global / regional groups of any local changes to PV.
• Safety Training
• Document self-training on drug safety reporting responsibilities and maintain awareness of drug safety reporting.
• Signal Detection
• Report potential single case signals or clusters in case processing as applicable.
• Submission to LHA
• Coordinate safety requirements for Marketing Authorization Holders (MAH).
• Translation
• Translate ICSR, PSUR, HA correspondence, regulatory intelligence as required.
• Other Process & Regulation
• Active participation in local trade associations and meetings with local Health Authorities.

Qualifications / Requirements

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