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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).
Ensuring 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.
Ensures that specified timelines and reporting requirements are met.
Having an appropriate system of PV and Risk Management in place in order 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
Creation and implementation of business continuity plans (e.g. inspection readiness, AE reporting and coverage).
Ensure an effective system is in place for 24-hour coverage.
Ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained at the Johnson & Johnson LOC level.

Case Processing
Key responsibility is to ensure that systems and processes are available for collection (initial and follow-up), review, reporting and reconciliation of Adverse Events (AEs), Adverse Events combined with Product Quality Complaints (AE+PQCs) and pregnancy reports obtained through the following sources: spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources.
Manage and maintain active involvement in day-to-day AE reporting as applicable (case registry, compliance with global organization requirements).
Accountable internally to ensure that the LOC meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports

Clinical trial compliance
Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs (PSP) to ensure appropriate safety reporting to Global Medical Safety (GMS) or appropriate case management center and LHA, as required.

Collaborate & Support
Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local HA to the appropriate global and regional groups as appropriate, supporting in the New Product Registration/Launch.
Collaborate with appropriate departments to identify the resources and expertise needed to address the question. This may include local, regional and/or global expertise.
Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs (PSP) to ensure appropriate safety reporting to GMS or appropriate case management center and HAs, as required.
Where applicable, support the QPPV to provide safety-related regulatory communication (e.g., response to request for information from local HAs, including the provision of information about the volume of sales or prescription, as appropriate.
Participate in the Product Issue Management teams, as appropriate.
Provide technical and strategic input and participate in projects led by the regional PV team and IPV work streams.

Inspection preparation & support
Always Ensure PV inspection readiness on the LOC level, managing and with oversight of any non-conformance and corrective/ preventive actions.
Assist inspectors / auditors, support document requests.
Address follow-up actions from findings; monitor non-LSO corrective actions.

Literature search
Identify local Medical/Scientific Literature not available to GMS, review for AEs and report as required per literature reporting criteria.
Support the review of literature search strategy.

New Safety Information
Take appropriate measures to ensure that new safety information is available to Health Care Professionals (HCP) in a timely manner, if applicable.

Other Safety Management & reporting
Oversight responsibilities of case processing operational activities delegated to the Regional Pharmacovigilance Case Management hub for Latin America or external vendor as appropriate.
Case processing activities include but not limited to Inbound reporting, outbound reporting, translation of AEs/Special Reporting Situations/PQCs, literature search, due diligence, and follow-up.

Oversight and providing input
Oversight of data generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs (e.g. patient support programs, market research surveys, internet sites), as applicable.
Assure all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
Support vendors qualification and oversight in the PV perspective
Safety oversight of clinical projects conducted in the territory as applicable

Procedural Document design
Ensure implementation of Global and Cross-Pharma Procedural Documents as applicable and/or write, validate and implement the Local Implementation Memos (LIM) for Regional / International PV Standard Operating Procedures/Working Practices and verify adherence.
Documentation storage management

Risk Management
Must have an appropriate system of PV and Risk Management in place in order to assure appropriate oversight for the implementation of Risk Management Activities for products within its responsibility.
Involvement in implementation of Risk Management Plans and Additional Risk Minimization Activities, if required.

Safety Policy/ Strategy
Ensure awareness of changes in regulations which may have an impact on PV activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups of any changes to local laws and regulations regarding PV.

Safety Training
Ensure proper documentation of self-training on drug safety reporting responsibilities and maintenance of awareness of drug safety reporting in general.

Signal Detection
Reporting of potential single case signals or clusters of similar events seen in case processing, as applicable.

Submission to LHA
Maintain overall responsibility for the coordination of safety requirements as required for Marketing Authorization Holders (MAH).

Translation
Translation of ICSR, PSUR, Health Authority (HA) correspondence, regulatory intelligence, as required.

Other Process & Regulation
Active participation in local trade associations
Meeting with local Health Authorities

Qualifications / Requirements:

Bachelor Degree Completed in health areas;
At least 1 year in a PV responsibility role.
At least Intermediate English language is required (comprehension and reading);
Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field;
General knowledge on healthcare and safety
Proven ability to organize workflow activities and manage multiple critical issues;
Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external stakeholders;

Other requirements
Demonstrable knowledge of all local PV requirements and of global aspects of drug Safety
Preferred experience in pharmacovigilance, not limited;
By preference, a minimum of 2 + years pharmaceutical industry