Full time

Holistique Training

Marbella

Sur place

EUR 40 000 - 65 000

Plein temps

14 jours+

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Qualifications

  • Proven experience as a trainer in pharmacoepidemiology or related RWE fields.
  • Background in industry, CRO, academia, health systems or regulatory bodies.
  • Deep knowledge of study design and advanced analytics for RWD.
  • Familiarity with GDPR, EMA guidance, HTA expectations.
  • Excellent communication and presentation skills.
  • Ability to design engaging, interactive training with case studies.

Responsabilités

  • Design and deliver an in-depth RWE training program covering foundations of RWD and study designs (cohort, case-control, cross-sectional).
  • Develop and utilize training materials, including presentations, hands-on labs (R/Stata/SAS/Python), real-world case studies, and practical exercises on protocol development and analysis plans.
  • Facilitate interactive sessions to help participants evaluate drug safety and effectiveness, interpret results, and translate evidence into regulatory, clinical, and public-health decisions.
  • Guide participants through advanced methods such as propensity score techniques, instrumental variable analysis, sensitivity analyses, and transparent reporting frameworks.
  • Provide expert insight into EU/Spain-relevant topics: GDPR for health data, EMA guidance, HTA considerations, pharmacovigilance signal evaluation, and emerging applications of RWE.
  • Conduct assessments and lead discussions to measure trainees’ understanding of study design, data handling, and result interpretation, culminating in project presentations.
  • Collaborate with the client to align the training with participant backgrounds (epidemiology, clinical, regulatory, analytics) and with accreditation expectaons (CPD/BAC/ISO standards).

Connaissances

RWE training
Epidemiology
Biostatistics
Regulatory concepts
Educational design

Outils

R
Stata
SAS
Python

Description du poste

Trainers/Instructors for Real‑World Evidence in Pharmacoepidemiology (Spain)

We are seeking a highly qualified and experienced pharmacoepidemiology or public health professional to deliver a comprehensive Real‑World Evidence (RWE) in Pharmacoepidemiology course in Spain. The ideal candidate will possess deep expertise in real‑world data (RWD) sources, study design, and advanced analytical methods, with a proven ability to translate complex statistical and regulatory concepts into practical, actionable training for healthcare and research professionals.

Key Responsibilities:

  • Design and deliver an in‑depth training program on RWE, covering foundations of RWD, study designs (cohort, case‑control, cross‑sectional), data quality and governance, and bias/confounding control.
  • Develop and utilize a range of training materials, including detailed presentations, hands‑on data analysis labs (R/Stata/SAS/Python), real‑world case studies, and practical exercises on protocol development and analysis plans.
  • Facilitate interactive sessions to help participants evaluate drug safety and effectiveness, interpret results, and translate evidence into regulatory, clinical, and public‑health decisions.
  • Guide participants through advanced methods such as propensity score techniques, instrumental variable analysis, sensitivity analyses, and transparent reporting frameworks.
  • Provide expert insight into EU/Spain‑relevant topics: GDPR for health data, EMA guidance, HTA considerations, pharmacovigilance signal evaluation, and emerging applications of RWE.
  • Conduct assessments and lead discussions to measure trainees’ understanding of study design, data handling, and result interpretation, culminating in project presentations.
  • Collaborate with the client to align the training with participant backgrounds (epidemiology, clinical, regulatory, analytics) and with accreditation expectaons (CPD/BAC/ISO standards).
Requirements
  • Proven experience as a trainer, instructor, or facilitator in pharmacoepidemiology, epidemiology, biostatistics, pharmacovigilance, or closely related RWE functions.
  • Substantial professional background in industry, CRO, academia, health systems, or regulatory/HTA bodies involving design and analysis of real‑world studies.
  • In‑depth knowledge of study design and advanced analytics for RWD, including propensity scores, instrumental variables, confounding/bias mitigation, and appropriate statistical testing.
  • Strong understanding of RWD sources (EHRs, registries, claims), data quality/integrity practices, and ethical/legal frameworks (GDPR; familiarity with EMA/HTA expectations).
  • Excellent communication, presentation, and interpersonal skills, with the ability to engage a diverse audience of clinicians, researchers, analysts, and decision‑makers.
  • Ability to create engaging, interactive training using case studies, hands‑on exercises, and clear methodological explanations.
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