Team Lead- Aggregate Reporting

  • Full Time
  • Mysore

Website Bioclinica

Desired Technical SkillS

Person should be familiar with MS Office Tools.

Extensive knowledge of US, ICH, and EU PV and GCP regulations

Excellent strategic decision-making and analytical skills

Safety database knowledge.

Specialized Knowledge And Skills
Basic competence with medical and therapeutic terminology.
Proven ability to analyze and interpret aggregate patient safety data relating to drug products
Ability to work independently but guided by documented procedures, with appropriate support.
Proven ability to interpret and follow the patient safety guidelines of the FDA and comparable international regulatory organizations such as the International Conference on Harmonization
Proven experience and report writing skills in accordance with agency requirements for content, format and timelines.
Able to work effectively as part of a team.
Understanding of patient safety regulatory obligations.

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