Local Safety Designee
hace 6 meses
At **Johnson & Johnson **, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.
Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, **YOU** are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.
At **Janssen **, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
We are Janssen.
Our mission drives us.
Our patients inspire us.
We are searching the best talent for** a Local Safety Designee (Fixed Term) **to be in **Bogota, Colombia **.**
**Purpose**: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 special reporting situation (SS) obtained through the following sources: spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources.
**Essential Duties**:
- Manage and maintain active involvement in day-to-day AE reporting as applicable.
- Accountable 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
- Translation of ICSR, PSUR, HA correspondence, regulatory intelligence, as required. 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 the all safety-related third-party agreements have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
- Safety oversight of clinical projects conducted in the territory as applicable. Clinical trial compliance
- Collaboration with Medical Affairs, clinical groups or other applicable groups for the review and approval of safety aspects of local, regional and global study protocols or Patient Support Programs (PSP) to ensure appropriate safety reporting to GMS or appropriate case management centre and RA, as required. Submission to RA
- Maintain overall responsibility for the coordination of safety requirements as required for Marketing Authorization Holders (MAH). Signal Detection
- Escalation potential single case signals or clusters of similar events seen in case processing, 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.). Literature search
- Identify local Medical/Scientific Literature not available to GMS, ensure AEs/SS/PQCs are identified, reviewed for AEs and reported as required per literature reporting criteria. Business Continuity
- Creation and implementation of PV business continuity plans (e.g. inspection readiness, AE reporting 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 Janssen LOC level. Risk Management
- LSO 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 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. Local PV Responsible
- Act as local nominated contact for PV.
- Where applicable, attach an annex for describing the role of legal local PV responsible person as defined by national law. Other
**Qualifications**:
**Qualifications**:
- Bachelor's Degree Completed.
- Intermediate / Advanced English level
- Sound knowledge of general medicine or pharmacy and clinical practi
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