Your Role:

The main accountability of the role is to provide various office and location support activities. Identifies, enhances and follows specific processes and procedures to maximize the efficiencies of the business to which the support is being provided; ensures the correct functioning of facilities, office and/or business support services. The SSC Coordinator is directly accountable for performing all Pharmacovigilance (PV) tasks allocated to the Local Patient Safety organizations under the supervision of the SSC Manager in a given SSC territory. Tasks have to be performed in full compliance with all relevant global and local regulatory requirements and company standards.

 

You will be responsible for: Product safety surveillance

  • Handling of all local drug safety information, including collection, registration, translation from local language into English, and transmission to GPS as applicable in a timely manner
  • Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner
  • Performing screening of relevant local medical/scientific literature in accordance with GPS procedures and local requirements (where applicable)
  • Performing screening of relevant local health authority web sites according to global standards as defined by relevant quality documents (where applicable)
  • Collaboration with medical information, quality assurance, complaint management and PDCSs to ensure safety reporting procedures are in place, safety relevant information is processed in a timely manner, and reconciliation is completed
  • Keeping product knowledge up-to-date to ensure appropriate Individual Case Safety Report (ICSR) handling
  • Performing required PV activities in the absence of the SSC Manager

 

Reporting to local Health Authorities and Ethics Committees:

  • Timely submission of expedited ICSRs to concerned local health authorities (where applicable)
  • Support of e-reporting in e-reporting ready countries (where applicable)
  • Timely submission of expedited cases to concerned local/central EC/IRBs as applicable
  • Timely submission of safety issue reports to concerned local health authorities
  • Timely submission of safety issue reports to concerned local/central EC/IRBs as applicable

 

Compliance related activities:

  • Using applicable tools (e.g. IRT) to ensure local compliance in terms of ICSR handling according to local regulations and company timelines
  • Supporting the SSC Manager to ensure compliance reports to GPS via the applicable technical tool (e.g. SCCT) in a timely manner
  • Contributions to the Local PV file in close collaboration with Local PV Responsible (LPVR) persons to support completeness, accuracy and that relevant information is updated in a timely manner

 

Tracking of clinical development and Patient Data Collection Systems (PDCS) activities in the assigned countries:

  • Supporting the SSC Manager that a complete overview on relevant local / global clinical studies and PDCS (ongoing and planned) in the local affiliates is kept
  • Supporting the SSC Manager that current global procedures for the handling of PDCS and clinical studies are followed

 

Training activities:

  • Completion of all mandatory PV trainings in a timely manner
  • Supporting PV training activities under the supervision of the SSC Manager
  • Supporting the SSC Manager in PV related trainings as required
  • SSCM deputy in case of SSCM absence of SSC Brazil (for example holidays, sick leave and extended absence from office)

Local Pharmacovigilance Responsible in front of Local health authority

 

Who you are:

Graduation in Healthcare (p.ex. Pharmacy, Medicine, Biomedicine)
Fluency in English and Spanish
Experience with leading people
Solid experience in pharmacovigilance area of pharmaceutical companies
Desirable previous experience working in multinational companies;
Job Requisition ID: 189784
Location: São Paulo - all
Career Level: D - Professional (4-9 years)
Working time model: full-time

 

Para se candidatar a esta vaga cadastre seu currículo no link https://jobs.vibrantm.com/merck/job/S%C3%A3o-Paulo-all-Drug-SafetyPharmacovigilance-Coordinator-04758-000/521208601/