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Job Title: Local Safety Officer
No of Posts: 01
Salary: As per company standards
- To ensure highest compliance in 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.
- Accountable internally for ensuring that the LOC meets procedurally defined timelines for management of safety information and local regulatory agency defined timeline for submission of individual reports.
- To ensure that data generating activities are reviewed for any solicitation for information and to ensure appropriate reporting of potential AEs (e.g. patient support programs, market research surveys, internet sites)
- Assure the all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
- 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 centre and RA, as required.
- Plan and ensure timely submission of Aggregate Reports according to local regulations
- Provide local data as required to support the preparation of Aggregate Safety Summaryreports (PSUR, DSUR, etc.).
- Identify local Medical/Scientific Literature not available to GMS, review for AEs and report as required per literature reporting criteria.
- Ensure that day-to-day PV functions are performed satisfactorily and that optimal regulatory compliance is maintaind at the Janssen LOC level.
- Ensure PV inspection readiness on the LOC level at all times.
- Ensure proper documented training on drug safety reporting responsibilities of Janssen LOC personnel and maintenance of awareness of drug safety reporting in general
- Ensure implementation of Global and Cross-Pharma Procedural Documents as applicable
Qualifications: MBBS, B. Pharm, M. Pharm, Post Graduate in any discipline of Medicine. Minimum of 2-3 years of experience in Pharmaceutical industry and Pharmacovigilance.