Opportunity for Sr Pharmacovigilance Physician "A"

Sr Pharmacovigilance Physician

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• Experience 0 to 3 yrs
• 

Job Description

JOB DESCRIPTIONApply knowledge and expertise including complex decision making activities to 
review, assess and process Lifecycle Safety data and information across all service lines. 
Recognized as specialist in one or more areas. Provide oversight on small to medium service 
operational projects and act as mentor to junior members of staff.RESPONSIBILITIES Receive, triage, 
review and process Lifecycle safety operational data from various sources on time, within budget 
and quality standards. Perform data entry for tracking and Lifecycle safety databases, coding 
relevant medical terminology, writing descript narratives, generating queries pertinent to the 
case, performing quality control, assisting with reconciliation, driving case closure, coordinating 
translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process 
material for endpoint committee or core laboratory adjudication. Preparation of material for 
submission. Assess Lifecycle safety data for report ability to relevant authorities, track 
reportable cases and report to regulatory authorities, ethics committees, institutional review 
boards, investigators, oversight groups per legislation, within timelines and in a format 
compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. 
Liaise with systems manager for regulatory tracking requirements and electronic reporting. 
Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety 
Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as 
appropriate. Receive and document incoming telephone calls, faxes or s from investigative sites or 
other sources reporting operational data. Process Lifecycle safety data according to applicable 
regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements. Build a 
positive, collaborative team environment with Lifecycle safety team members, lead by example, 
provide training and mentoring for less experienced team members and operations staff, assist 
Operations with appropriate allocation of resource. Provide oversight role and have a good 
understanding of operational team on status, metrics, productivity and initiatives. Provide and 
impart technical and process information to Lifecycle Safety Management (LSM) and members of 
operational team on project specific issues. Provide oversight and maintain a thorough 
understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for 
assigned projects set up and maintain project files, standards, templates, electronic forums, 
databases and workflow. Establish and maintain effective team project service operations 
communications i.e. provide regular feedback to operations team manager and Customer Delivery 
manager (CDM) on project metrics, out of scope work challenges/issues and successes feedback 
effective project performance to junior members of team. Liaise with LSM in proactively identifying 
issues and proposing solutions, providing them with technical support, reports, metrics, statuses, 
identifying SOW changes and potential change orders ,delegating client requests and installation of 
new initiatives. Ensure compliance to Quintiles high quality standards and works with LSM 
constructively in a matrix framework to achieve project and customer deliverables. Participate in 
training across Lifecycle safety process service offerings, participate in working groups as 
applicable in implementation of new initiatives, identification and implementation of process 
efficiencies. Liaise confidently with different functional team members, e.g. project management, 
clinical, data management, health care professionals e.g. investigators, medical monitors, site 
coordinators and designees to address operational project issues. Contribute to achieving 
productivity utilization and realization metrics. Read and acknowledge all necessary Quintiles 
standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is 
executed in a timely fashion and documented. Work towards ensuring your individual training plan 
and training transcript are reconcilable. Perform other duties as assigned.REQUIRED KNOWLEDGE, 
SKILLS AND ABILITIES In depth knowledge of Lifecycle safety processes and willingness and aptitude 
to learn new skills across Lifecycle safety service lines. In depth knowledge and understanding of 
applicable global, regional, local clinical research regulatory requirements i.e. Good Clinical 
Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs. Proven ability 
to meet strict deadlines manage competing priorities. Demonstrate effective project management and 
leadership skills. Sound judgment independent thinking and decision making skills. Demonstrate a 
flexible and receptive approach to changing demands. Proven ability to work independently and 
autonomously with policies and practices. Effective mentoring and coaching skills. Excellent 
attention to detail and accuracy maintaining consistently high quality standards. Excellent 
organizational skills and time management skills. Excellent written/verbal communication and report 
writing skills. Ability to establish and maintain effective working relationships with coworkers, 
managers and clients. Ability to work effectively on multiple projects simultaneously organize own 
workload and effectively manage competing QualificationsMINIMUM REQUIRED EDUCATION AND EXPERIENCE 
Bachelor s Degree in a Health Science and 3 years experience of Lifecycle safety 
(Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc)or equivalent 
combination of education, training and experience.PHYSICAL REQUIREMENTS Extensive use of keyboard 
requiring repetitive motion of fingers. Extensive use of telephone and face-to-face communication 
requiring accurate perception of speech. Regular sitting for extended periods of time. May require 
occasional travel.
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | 
B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other 
Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 2-7



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