Safety Specialist (Functional Service Partnership) - Contract Opportunity

Submission for the position: Safety Specialist (Functional Service Partnership) - Contract Opportunity - (Job Number: 168102)

PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY

*Home-Based/Remote Based Contract Opportunity*Full Time (FTE 1.0)*3-6 month duration

Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture?

Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team. Functional Service Partnership Homepage: https://www.ppd.com/our-solutions/clinical/fsp/

The Safety Specialist will perform day-to-day adverse event reporting and subsequent Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information.

Will coordinate and perform adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Will effectively collaborate with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors. Possibility to assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.

PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY

*Home-Based/Remote Based Contract Opportunity*Full Time (FTE 1.0)*3-6 month duration

Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture?

Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team. Functional Service Partnership Homepage: https://www.ppd.com/our-solutions/clinical/fsp/

The Safety Specialist will perform day-to-day adverse event reporting and subsequent Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information.

Will coordinate and perform adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Will effectively collaborate with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors. Possibility to assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings. Minimum Required Education and Experience:

Bachelor’s degree in Nursing, Medical Technology or Pharmacy with 2 years of clinical experience OR Life Science degree with 2 years of clinical experience and 1 year of pharmacovigilance experience

Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the jobRequired Knowledge, Skills and Abilities:General understanding of pathophysiology and the disease processDetailed knowledge of relevant therapeutic areas as required for processing AEsStrong critical thinking and problem solving skillsGood oral and written communication skills including paraphrasing skillsGood command of English and ability to translate information into local language where requiredComputer literate with the ability to work within multiple databasesPrevious exposure to Microsoft Office packages (including Outlook, Word, and Excel)Understanding the importance of and compliance with procedural documents and regulationsAbility to manage and prioritize a variety of tasks and meet strict deadlines with limited supervisionStrong attention to detailAbility to maintain a positive and professional demeanor in challenging circumstancesAbility to work effectively within a team to attain a shared goalWorking Conditions:Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international.Physical Demands:Frequently stationary for 6-8 hours per day.

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck.

Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups.

Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.

Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.

Minimum Required Education and Experience:

Bachelor’s degree in Nursing, Medical Technology or Pharmacy with 2 years of clinical experience OR Life Science degree with 2 years of clinical experience and 1 year of pharmacovigilance experience

Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the jobRequired Knowledge, Skills and Abilities:General understanding of pathophysiology and the disease processDetailed knowledge of relevant therapeutic areas as required for processing AEsStrong critical thinking and problem solving skillsGood oral and written communication skills including paraphrasing skillsGood command of English and ability to translate information into local language where requiredComputer literate with the ability to work within multiple databasesPrevious exposure to Microsoft Office packages (including Outlook, Word, and Excel)Understanding the importance of and compliance with procedural documents and regulationsAbility to manage and prioritize a variety of tasks and meet strict deadlines with limited supervisionStrong attention to detailAbility to maintain a positive and professional demeanor in challenging circumstancesAbility to work effectively within a team to attain a shared goalWorking Conditions:Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international.Physical Demands:Frequently stationary for 6-8 hours per day.

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck.

Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups.

Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.

Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.

IE-IE-Dublin, FR-FR-France, BG-BG-Sofia, BG-BG-Sofia-FSP Sofia BG Tsarigradsko Shos, IE-IE-Dublin-FSP DUBLIN IE Rathfarnham, GB-GB-Winchester, BG-BG-Sofia-Sofia 115G Tsarigradsko Shosse, United Kingdom, GB-GB-Middlesex-FSP Uxbridge UK Stockley Prk W, ES-ES-Madrid-Madrid ES - Titan, 15, France, GB-United Kingdom, FR-France, IE-Ireland, FR-FR-Ivry-sur-Seine Ced-Ivry-sur-Seine Cedex FR PVC, GB-GB-Middlesex, BG-Bulgaria, IE-IE-Athlone-Athlone IE Business & Tech Pk, BE-BE-Brussels-Brussels BE St Stevens Woluwe, GB-GB-Stevenage-FSP Stevenage UK, IE-IE-Athlone, Spain, IT-Italy, GB-GB-Stevenage, GB-GB-Winchester-Winchester GB 1-2 Crown Walk, FR-FR-France-FSP MarlyleRoi FR Versaille Rd, GB-GB-Bellshill-Bellshill GB Fleming House 1, GB-GB-Bellshill, Italy, BE-BE-Brussels, Belgium, DE-Germany, IT-IT-VERONA-FSP VERONA IT FSP Fleming, DE-DE-Munich-FSP Munich DE Prince Regent Sq, DE-DE-Nuremberg, ES-ES-Madrid-FSP Madrid ES Plaza de Carlos, BE-Belgium, DE-DE-Munich, DE-DE-Karlsruhe, Germany, ES-Spain, IT-IT-VERONA, IT-IT-Segrate (MI), DE-DE-Karlsruhe-Karlsruhe DE, IT-IT-Segrate (MI)-Milano IT Via San Bovio, ES-ES-Madrid, DE-DE-Munich-Munchen DE Hansastrasse, BE-BE-Rixensart-Rixensart FSP, BE-BE-Wavre-FSP Wavre BG Avenue Pascal, Bulgaria, Ireland, FR-FR-Ivry-sur-Seine Ced, BE-BE-Rixensart, BE-BE-Wavre, BE-BE-Zaventem, DE-DE-Nuremberg-Nuremberg DE Sulzbacher Str.48, GB-GB-Cambridge-Cambridge GB Granta Park1, GB-GB-CambridgeIE-IE-Dublin, FR-FR-France, BG-BG-Sofia, BG-BG-Sofia-FSP Sofia BG Tsarigradsko Shos, IE-IE-Dublin-FSP DUBLIN IE Rathfarnham, GB-GB-Winchester, BG-BG-Sofia-Sofia 115G Tsarigradsko Shosse, United Kingdom, GB-GB-Middlesex-FSP Uxbridge UK Stockley Prk W, ES-ES-Madrid-Madrid ES - Titan, 15, France, GB-United Kingdom, FR-France, IE-Ireland, FR-FR-Ivry-sur-Seine Ced-Ivry-sur-Seine Cedex FR PVC, GB-GB-Middlesex, BG-Bulgaria, IE-IE-Athlone-Athlone IE Business & Tech Pk, BE-BE-Brussels-Brussels BE St Stevens Woluwe, GB-GB-Stevenage-FSP Stevenage UK, IE-IE-Athlone, Spain, IT-Italy, GB-GB-Stevenage, GB-GB-Winchester-Winchester GB 1-2 Crown Walk, FR-FR-France-FSP MarlyleRoi FR Versaille Rd, GB-GB-Bellshill-Bellshill GB Fleming House 1, GB-GB-Bellshill, Italy, BE-BE-Brussels, Belgium, DE-Germany, IT-IT-VERONA-FSP VERONA IT FSP Fleming, DE-DE-Munich-FSP Munich DE Prince Regent Sq, DE-DE-Nuremberg, ES-ES-Madrid-FSP Madrid ES Plaza de Carlos, BE-Belgium, DE-DE-Munich, DE-DE-Karlsruhe, Germany, ES-Spain, IT-IT-VERONA, IT-IT-Segrate (MI), DE-DE-Karlsruhe-Karlsruhe DE, IT-IT-Segrate (MI)-Milano IT Via San Bovio, ES-ES-Madrid, DE-DE-Munich-Munchen DE Hansastrasse, BE-BE-Rixensart-Rixensart FSP, BE-BE-Wavre-FSP Wavre BG Avenue Pascal, Bulgaria, Ireland, FR-FR-Ivry-sur-Seine Ced, BE-BE-Rixensart, BE-BE-Wavre, BE-BE-Zaventem, DE-DE-Nuremberg-Nuremberg DE Sulzbacher Str.48, GB-GB-Cambridge-Cambridge GB Granta Park1, GB-GB-CambridgeSubmission for the position: Safety Specialist (Functional Service Partnership) - Contract Opportunity - (Job Number: 168102)