Sr Pharmacovigilance Physician
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
Company Information: Premium jobs is a place, where you will get good companies jobs all
together.
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