Lead Safety Operations, Pharmacovigilance

THE POSITION: This Position supports the client Pharmacovigilance (PV) Department as a team leader in processing and analyses of safety data and managing the PV safety operations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:

 Manage Day to Day work allocation, compliance, Quality for PV projects.

 Understand and effectively manage the teams governance and performance

 Understand the level of risk & propose mitigation plans and partner with other support teams to resolve requests/issues in a timely manner

 Clearly communicate team goals and deliverables and keep the team updated on changes

 Coach team members and provide the first level advice on procedures/methods

 Solve increasingly complex problems & effectively delegate to develop and groom team members for succession planning

 Maintain client relationships interface through regular connects and emails

 Understand client priorities and problems & help translate actions for the team

 Use innovation to identify opportunities to optimize processes, decrease costs and increase client value

 Use data analytics and story-telling techniques to enhance the client journey

 Perform Case processing Related Activities like Case Processing, Quality Check, Report generation through Database and Report authoring.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

BS degree in a life science discipline (e.g., pharmacy, nursing) is preferred

 8-10 years of relevant experience is preferred, including 7-8 years of experience in drug safety

 Good Experience in People and workflow Management in PV domain

 Broad knowledge of domestic and international drug safety regulations, industry practices and standards  Strong attention to detail, teamwork, and initiative

 Strong understanding of drug development, drug safety reporting, as well as an appreciation for the importance of regulatory compliance

 Excellent working knowledge of MedDRA and WHODRUG coding dictionaries

 Familiarity with FDA and international adverse event reporting regulations per ICH guidelines

 Understanding of medical terminology and familiarity with principles of adverse event reporting in the pharmaceutical industry is a plus

 Must be quality oriented and demonstrate consistent attention to detail

 Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required  Must have good planning and organizational skills

 Knowledge of relevant software including safety database and Microsoft Office along with Good Excel Skills