Work as Senior Pharmacovigilance Specialist at Clinipace
- 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.
- 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.
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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