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Especialista De Farmacovigilancia

Especialista De Farmacovigilancia
Empresa:

Johnson & Johnson


Detalles de la oferta

The Janssen PharmaceuticalCompanies of Johnson & Johnson are dedicated to addressing and solving themost important unmet medical needs of our time, including oncology (e.g.,multiple myeloma and prostate cancer), immunology (e.g., rheumatoid arthritis,irritable bowel disease and psoriasis), neuroscience (e.g., schizophrenia,dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C andtuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).Driven by our commitment to patients, we develop sustainable, integratedhealthcare solutions by working side-by-side with healthcare stakeholders,based on partnerships of trust and transparency.

Primary responsibility:

- Ensuring that the activitiesare managed in compliance with local regulations and companypolicies/procedures at a local, regional and global level and in accordancewith any PV agreements with third party business partners.
- Having an appropriate system ofPV and Risk Management in place in order to assure appropriate oversight forproducts within its responsibility.
- Managing and coaching local PVstaff, if appropriate.
- Key responsibility is to ensurethat systems and processes are available for collection (initial andfollow-up), review, reporting and reconciliation of Adverse Events (AEs),Adverse Events combined with Product Quality Complaints (AE+PQCs) and pregnancyreports obtained through the following sources: spontaneous, solicited,clinical trials, data generating activities, local Regulatory Authorities (RAs)and all other potential sources.
- Manageand maintain active involvement in day-to-day AE reporting as applicable.
- Oversight of data generatingactivities to ensure any solicitation for information includes an appropriatereview and reporting process for reporting potential AEs (e.g. patient supportprograms, market research surveys, internet sites), as applicable.
- Assure the all vendor contractshave appropriate Pharmacovigilance language incorporated and that thesecontracts are archived in the global system, as applicable.
- Safety oversight of clinicalprojects conducted in the territory as applicable.
- Collaboration with MedicalAffairs for the review and approval of safety aspects of local study protocolsor Patient Support Programs (PSP) to ensure appropriate safety reporting to GMSor appropriate case management centre and RA, as required.
- Identify localMedical/Scientific Literature not available to GMS, review for AEs and reportas required per literature reporting criteria.
- Ensure an effective system isin place for 24-hour coverage. (Activity delegated in COE)
- Involvement in implementationof Risk Management Plans and Urgent Safety Restrictions, if required.
- Coordinate the provision ofsupport for third party safety agreements with PV implications at the locallevel and ensure the PV agreement is implemented locally, as appropriate.
- Ensure implementation of Globaland Cross-Pharma Procedural Documents as applicable and/or write, validate andimplement the Local Implementation Memos (LIM) for Regional / International PVStandard Operating Procedures/Working Practices and verify adherence.
- Ensure awareness of changes inregulations which may have an impact on PV activities and responsibilities.Evaluate the impact on local processes and inform the appropriate global andregional groups (i.e. QPPV offices and IPV Regional Heads) of any changes tolocal laws and regulations regarding PV.

Qualifications

- Sound knowledge of generalmedicine or pharmacy and clinical practice, or relevant scientific/medicalfield.
- Proven ability to organizeworkflow activities and manage multiple critical issues.
- Awareness of and familiaritywith industry principles of PV, drug development and pharmacology.
- Computer literate withknowledge of relevant IT safety systems.
- Excellent verbal and writtencommunication skills with proven ability to negotiate and communicate withinternal and external customers.

Primary Location
Argentina-Buenos Aires-Capital Federal-Mendoza 1259
Organization
Janssen Cilag Farmaceutica Srl (fka Pharma Farmace (7425)
Job Function
R&D
Requisition ID
00001FXI


Fuente: Bebee2

Requisitos


Conocimientos:
Especialista De Farmacovigilancia
Empresa:

Johnson & Johnson


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