Junior Pharmacovigilance Analyst

**Essential Job Duties and Responsibilities**
- Reporting
oThe LSD/PV Analyst is an employee of the Local Operating Company (LOC).
- The LSD/PV Analyst has a direct reporting line into the Local safety Officer (LSO) of the LOC for the local PV system.
- Primary responsibility
- 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.
- Having an appropriate system of PV and Risk Management in place in order to assure appropriate oversight for products within its responsibility.
- Delegation
oComponents of the LSD/PV Analyst role may be delegated, with appropriate documentation.
oThe LOC management is the sole responsible party for ensuring that the overall requirements of the LSD/PV Analyst function are met. This responsibility cannot be delegated.
- Case Processing
oKey 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.
oManage and maintain active involvement in day-to-day AE reporting as applicable (case registry, compliance with global organization requirements)
oAccountable internally for ensuring that the LOC meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
- Translation
oTranslation of ICSR, PSUR, Health Authority (HA) correspondence, regulatory intelligence, as required.
- Oversight and providing input
oOversight 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.
oAssure all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
oSafety oversight of clinical projects conducted in the territory as applicable.
- Clinical trial compliance
oCollaboration 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 HA, as required.
- Submission to HA
oMaintain overall responsibility for the coordination of safety requirements as required for Marketing Authorization Holders (MAH).
- Signal Detection
oReporting of potential single case signals or clusters of similar events seen in case processing, as applicable.
- Aggregate reporting
oPlan and ensure timely submission of Aggregate Reports according to local regulations.
oProvide local data as required to support the preparation of Aggregate Safety Summary reports (PSUR, DSUR, etc.).
- Literature search
oIdentify local Medical/Scientific Literature not available to GMS, review for AEs and report as required per literature reporting criteria.
- Business ContinuityoCreation and implementation of business continuity plans (e.g. inspection readiness, AE reporting coverage).
oEnsure an effective system is in place for 24-hour coverage.
oEnsure that day-to-day PV functions are performed satisfactorily and that optimal regulatory compliance is maintained at the Janssen LOC level.
- Risk ManagementoLSD/PV Analyst 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.
oInvolvement in implementation of Risk Management Plans and Urgent Safety Restrictions, if required.
- 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
oOversight 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.
- Agreements / Contracts containing PV Language
oPerform contract review and maintain oversight to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.
oCoordinate 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.
- Inspection preparation & supp

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