Sr Safety Admin (night shift)
Pharmaceutical Product Development (PPD)
Taguig City, PH
6d ago

Provides safety support, which includes database entry, scanning, quality control of scanned documents, report distribution internally and to external clients and project file creation and maintenance, to the Pharmacovigilance department (PVG).

Collaborates with the safety team to ensure information received is logged, distributed, entered into a tracking database and appropriately filed.

Responsible for any departmental administrative tasks as delegated by the PVG management team. Mentors and trains new safety support staff.

Performs project support functions.

Essential FunctionsProvides primary safety support to Pharmacovigilance staff including receipt of information, copying, filing, typing and distribution of letters, memos, reports, sending faxes and mailings, etc.

Trains and provides leadership and direction to safety support staff for departmental administrative and project related tasks.

This may include directing work flow processes under the supervision of applicable PVG staff.May perform any or all of the following functions : Serve as back-up for safety administrator staffLogs information into tracking systemsUploads documents received within the designated document repositoryGenerates and distributes project reports to the client and project team.

Assists in the collation of study metrics for the team and archival of project documentation at closeoutResponsible for the set-up, management, and archival of program information through an administrative filing system so that information is readily available and accessibleAssists in the development of project-specific SOPs / WPDsCreates and tracks safety report submission packetsCompletes initial data entry of adverse events in the safety tracking system and / or safety databaseAssists with the development of and responsible for the maintenance of project specific training manual / matrix in collaboration with the PVG ManagerManages logistics and coordinates meetings for endpoint assessment committee / Data Safety Monitoring CommitteeResponsible for audit readiness in collaboration with PVG managementPerforms other duties as assignedProvides safety support, which includes database entry, scanning, quality control of scanned documents, report distribution internally and to external clients and project file creation and maintenance, to the Pharmacovigilance department (PVG).

Collaborates with the safety team to ensure information received is logged, distributed, entered into a tracking database and appropriately filed.

Responsible for any departmental administrative tasks as delegated by the PVG management team. Mentors and trains new safety support staff.

Performs project support functions.

Essential FunctionsProvides primary safety support to Pharmacovigilance staff including receipt of information, copying, filing, typing and distribution of letters, memos, reports, sending faxes and mailings, etc.

Trains and provides leadership and direction to safety support staff for departmental administrative and project related tasks.

This may include directing work flow processes under the supervision of applicable PVG staff.May perform any or all of the following functions : Serve as back-up for safety administrator staffLogs information into tracking systemsUploads documents received within the designated document repositoryGenerates and distributes project reports to the client and project team.

Assists in the collation of study metrics for the team and archival of project documentation at closeoutResponsible for the set-up, management, and archival of program information through an administrative filing system so that information is readily available and accessibleAssists in the development of project-specific SOPs / WPDsCreates and tracks safety report submission packetsCompletes initial data entry of adverse events in the safety tracking system and / or safety databaseAssists with the development of and responsible for the maintenance of project specific training manual / matrix in collaboration with the PVG ManagerManages logistics and coordinates meetings for endpoint assessment committee / Data Safety Monitoring CommitteeResponsible for audit readiness in collaboration with PVG managementPerforms other duties as assignedQualifications : Education and Experience :

Bachelor's degree required2 years of experience providing administrative support in pharmacovigilance (clinical or post -approval) or 1 year as a Safety Admin II

Or equivalent combination of education, training and experience that provides the knowledge, skills and abilities to perform the job

Knowledge, Skills and Abilities :

  • Strong written and verbal communications skills in EnglishAbility to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members and other internal staffGood computer skills to include : MS Office (Word, Excel, PowerPoint, Access) database experience and the ability to create and design reports;
  • understanding, knowledge of safety databasesExcellent office skills (including filing, scanning and faxing)Ability to work within specified proceduresAbility to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlines;
  • ability to maintain focus while working with strict timelinesStrong attention to detail and accuracy with orientation toward careful and meticulous workAbility to work effectively within a team to attain a shared goalAbility to work independently with minimal supervisionStrong problem solving skillsAbility to assist in the management of a large project and to provide work direction and training to other safety support staff working on the projectFirm knowledge of medical terminology

    Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and / or local law.

    Qualifications : Education and Experience :

    Bachelor's degree required2 years of experience providing administrative support in pharmacovigilance (clinical or post -approval) or 1 year as a Safety Admin II

    Or equivalent combination of education, training and experience that provides the knowledge, skills and abilities to perform the job

    Knowledge, Skills and Abilities :

  • Strong written and verbal communications skills in EnglishAbility to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members and other internal staffGood computer skills to include : MS Office (Word, Excel, PowerPoint, Access) database experience and the ability to create and design reports;
  • understanding, knowledge of safety databasesExcellent office skills (including filing, scanning and faxing)Ability to work within specified proceduresAbility to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlines;
  • ability to maintain focus while working with strict timelinesStrong attention to detail and accuracy with orientation toward careful and meticulous workAbility to work effectively within a team to attain a shared goalAbility to work independently with minimal supervisionStrong problem solving skillsAbility to assist in the management of a large project and to provide work direction and training to other safety support staff working on the projectFirm knowledge of medical terminology

    Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and / or local law.

    2020-08-24 00 : 00 : 00

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