Work as Senior Pharmacovigilance Specialist at Clinipace

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Skills/Competencies:

  • General knowledge of drug therapy, disease states, clinical research.
  • Applies working knowledge of pharmacvigilance processes and requirements to complex situations.
  • Advanced medical knowledge, ability to analyze, draw conclusions, and formulate recommendations related to potential safety issues.
  • Excellent computer knowledge. Use of MS office applications to a competent standard for Word, Excel, and PowerPoint.
  • Sound working knowledge of regulatory reporting requirements and international regulations (EU, US ,Japan and Asia).
  • Experience with team leading roles or comparable leadership functions.
  • Willingness to provide guidance and training to less experienced staff.
  • Willingness for continous on the job training and qualitfications measures.
  • Basic understanding of financial aspects of projects.
  • Practices professionalism and integrity in all actions – demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
  • Works through conflict and drives productive resolution.

Capabilities:

  • Ability to prepare draft working procedures, templates and/or training material
  • Ability to review and provide input for SOPs, working procedures, and guidelines
  • Ability to review and give input to Draft Safety Safety Management Plan (SMP)
  • Ability to provide quality control (QC) of scheduled expedited reports within safety database and/or designated EDC system (e.g. TEMPO) as applicable.
  •  Ability to process or retrieve safety information, initating searches and/ or generate reports from the safety database or designated EDC system  (e.g.TEMPO), as applicable.
  • Ability to maintain and protect client, patient and corporate confidentiality.
  • Ability to work in an environment of rapidly changing priorities and manage multiple client projects.
  • Ability to review medical data from clinical trials and post-marketing experiences, as applicable.
  • Ability to organize and manage work to meet strict timelines.
  • Ability to provide exceptional customer service and professional interactions with a varied customer base, as necessary.
  • Ability to work independently with high reliability and a high sense of responsibility.
  • Ability to work as a member of a team and possession of confident communication skills both written and verbal.
  • Ability to communicate in English (both written and verbal) .
  • Ability to work with careful attention to details.
  • Up to  10 % travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.

Additional Information:
Experience: 3-4 years
Qualification: Graduate with  a life science / Pharmacy
Location:  Trivandrum, India
Industry Type: Pharma
Functional Area: Pharmacovigilance
Last date : 15th May, 2017

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