Drug Safety Lead (pharmacovigilance) at Nefer HR Consulting Pvt Ltd
Posted by: Nefer HR Consulting Pvt Ltd
Posted date: 30-Jul
Job Description:*Identify and select routine cases for processing, determining and leveraging appropriate prioritization criteria, and noting reasons for any delays. *Split and merge cases by analyzing cases for specific criteria and cross-referencing split cases. *Assess and process case all case types. *Review, rank, verify, process, and document: event terms case classifications (validity, seriousness) special scenarios product complaint information medical device adverse events reportability with due date and accuracy and consistency. Based on assessment of cases, process accordingly. *Prepare initial and follow up case narratives. *Determine and perform appropriate case follow-up, generating follow-up letters. *Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios. *Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested. *Act as subject matter expert to members of US DSU and PSSR, and, liaise with key partners (e.g., License Partners, Clinical Development) regarding safety data collection and data reconciliation. *Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead within the DSU by contributing to the development of training applying expertise and knowledge to shape the strategic direction of the group advancing continuous improvement initiatives for US DSU work processes and representing the interests of DSU. *Develop and maintain advanced knowledge of: corporate and global regulations, guidelines, Standard Operating Procedures and writing practices data entry conventions and search functions in the safety database and data mart. *Provide oversight of team mentoring across teams on case handling aspects, data extraction, and analyses. *Consistently apply regulatory requirements and Client policies.
Desired Candidate Profile*Bachelor of Science required - Healthcare Profession preferred *Solid working knowledge of pharmacovigilance concepts *Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals *Excellent understanding of medical terminology and familiarity with principles of clinical assessment of adverse events in the context of an international pharmaceutical industry *Knowledge of US and EU regulations and guidelines for pharmacovigilance *Clinical experience in hospital or pharmacy familiarity with clinical assessment an advantage *Ability to independently solve routine problems related to core case processing and surface issues constructively *Ability to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact *Ability to discern when additional input is required to effectively address unique and/or complex situations *Understanding and ability to use computer technology, management of relational database systems, including extraction of data *Ability to work independently to accomplish team goals with minimal supervision *Demonstrated ability to foster teamwork and to work in a matrix organization *Fluency in spoken and written English knowledge of additional language(s) an advantage
Experience Required: 3 to 6
Education Required: (UG - Any Graduate - Any Specialization, Graduation Not Required, B.Pharma - Pharmacy, BDS - Dentistry, B.Sc - Nursing) OR (PG - Any PG Course - Any Specialization, Post Graduation Not Required, M.Pharma)
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