Looking for freshers who has completed their graduation B.Pharma/M.Pharma/ BDS/ M.Sc/B.Tech.
Provide intake and tracking of initial safety and clinical event validation and adjudication (CEVA) data. Transfer incoming
safety/CEVA data to project team. Identify any problems with incoming faxes and bring them to the attention of the senior
team member.
Distribute safety data to marketing authorization holders, customers, regulators and investigators.
Specific project responsibilities include set-up and/or maintenance of safety/CEVA files for reported events; archiving of
files when closed; coordination of transfer of archived material to company/customer archive storage facilities;
preparation and assistance in setting-up and updating project files; maintenance of personal safety files for mail merges
and regulatory documents; where required, data entry of events into tracking database and assistance of transfer of
events to customers.
Provide administrative support for the department by coordinating team/department/customer meetings, coordinating
stationery orders, dispatching data via courier services, reserving meeting rooms and IT equipment; and providing
secretarial support as required.
Generate and distribute alert letters.
Identify and record quality problems and bring them to the attention of a senior team member.
Provide training/mentoring new/less experienced staff.
Assist project lead and CEVA management with specific aspects of CEVA processes.
Set up and maintain Serious Adverse Event (SAE) files for reported events; organize and send files for archive when
events are closed.
Coordinate, schedule and submit reports to regulatory authorities in accordance with deadlines.
Coordinate distribution of safety letters to study investigators and Clinical Research Associates.
Assist in processing incoming and outgoing Adverse Event (AE) reports by collecting and tracking incoming AE reports
sent via fax, email, eCRF, etc; determining initial/update status of incoming events; tracking timelines for completion of
AE processing; performing data entry into safety database; routing report information to appropriate PhV project
personnel in the workflow for continued processing; performing quality control activities as directed by project lead or
manager; generating established safety data reports; submitting AE reports to client and other project team members
identified by project lead; obtaining confirmation of report receipt and track submission; and assuming workflow
responsibilities for local and global projects.
Perform records management tasks such as creating and tracking case folders for AE reports; filing, retrieving and
delivering case folders; assisting in maintenance of document control room and relevant applications/systems as directed
by manager; archiving case folders and project files; assisting in creation of PhV records management processes and
procedures; providing key input to management on acquisition and/or upgrade of records management
application/systems; and serving as liaison between Pharmacovigilance department and records management
department.
Assist with system support tasks such as utilizing design specifications, AE form, and protocol, creating projectspecific
entry specifications and annotated AE forms for safety database with direction from project lead and/or manager;
creating project tracking spreadsheets and associated tracking entry specifications; assisting in database validation
through performance of user testing; performing ad hoc database searches for project team leads; assisting project lead
in assessing database setup needs; and assisting with assuring systems issues are reported and resolved.
Perform additional project-related and administrative tasks such as handling investigator mailings including creation of
labels using investigator list, copying of documents, envelope stuffing, and tracking and filing of submitted materials;
creating and maintain project files; working with project lead to develop project instructions; performing reconciliation
between the safety and clinical databases; distributing AE listings to client and/or project team members; performing
project start-up tasks; providing project metrics to management; and assisting with data entry, workflow and deadline
quality measurements.
Participate in continuous improvement of all departmental processes and procedures.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Basic knowledge of ICH and GCP
Basic knowledge of medical terminology if processing
Good understanding of Core Operating Procedures (COPs)
Word processing and data entry skills
Strong organizational skills and time management skills
Flexibility and excellent verbal and written communication skills
Ability to deal successfully with many internal clients competing for attention, services and resources
Good attention to detail and accuracy
Ability to establish and maintain effective working relationships with co-workers, managers and colleagues.
Highly motivated and organised with a flexible attitude
Ability to follow instructions/guidelines, utilize initiative and work independently
Ability to establish and maintain effective working relationships with coworkers, managers and clients
APPLY ONLINE
