Senior Medical Safety Advisor

IQVIA

Lisbon, Portugal

há 5 dias

Role & Responsibility

Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions;

ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary

Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data

Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported

Ensure service delivery from productivity, compliance and quality perspective within regulatory / contracted timelines.

Lead and participate in the initiatives taken for the same from team delivery perspective

Provide therapeutic area / pharmacovigilance issue guidance in the context of leading / managing other safety team members in single case assessment.

Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable

Maintain awareness of medical safety-regulatory industry developments

Qualification (Essential)

Physician's license (exclude Chinese traditional medicine)

Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate and / or Residency training can qualify for clinical practice experience

English language proficiency in reading and writing (e-learning programs will be provided in English)

Qualification (Nice to have) :

Sound knowledge of Medicine

In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Knowledge of Pharmacovigilance - ICSR and Aggregate reports

Any experience in clinical trials and pharmacovigilance.

Adequate Computer skills, especially Microsoft word, excel & PowerPoint

Good communication skills- verbal and written

Ability to establish and maintain effective working relationships with managers, co-workers, investigativesite staff, clients and regulatory agency representatives

Ability to establish and maintain effective working relationships with coworkers, managers and clients

Location : Homebased

Workstyle Options :

Full-time (7.5 hours / day)

Part-time (At least consecutive 3 hours / day

3 days / week 9 hours / week as minimum)

LI-SN2

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