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The Pharmacovigilance Analyst will provide technical and process-related support to Prevail’s pharmacovigilance and medical monitoring activities, ensuring compliance with relevant global regulations and Standard Operating Procedures (SOPs).

Responsibilities:

• Management of safety cases and reports from all sources, including case intake/triage, data entry, quality review, medical review, and follow up activities
• Electronic documentation and filing of safety information according to SOPs and safety management processes
• MedDRA coding of data in the safety database
• Preparation of case narratives
• Reconciliation of the clinical and safety databases
• Provide support for regulatory submission preparation and review
• Coordinate safety project setup, including safety database build
• Author sponsor/project specific safety management plans
• Conduct and assess literature searches
• Participate in sponsor/investigator meetings as required
• Maintain a working knowledge of the safety database
• Maintain working knowledge of global regulatory rules and regulations, including monitoring for new or changing regulation
• Perform other duties as assigned

Requirements

• Pharmacovigilance knowledge and experience including safety case processing for clinical trials (drugs, biologics, vaccines, and medical devices). Nursing experience is a plus.
• Proficient in MS Office and Adobe Acrobat
• Good Understanding of MedDRA & WHODrug Global dictionaries
• Must display analytical and clinical skills
• Requires narrative writing skills

Education and Experience:

Degree in Nursing, Life Science, or other health-related field, or equivalent qualification/work experience

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

Ethics – Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Customer Service – Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; ensures the IDM team is meeting project commitments.

Teamwork – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone’s efforts to succeed.

Professionalism – Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.

Work Environment – This job is based out of our headquarters in Philadelphia, PA but will be a remote position.

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

This is an equal employment opportunity and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.

We are expanding our Clinical Data Management team with people who have drive, creativity, self-motivation, and professionalism. We are seeking an Associate Director for our Information and Data Management department with a minimum of 10 years experience and 5 years in leading DM projects.

Job Responsibilities and Requirements

• Participates in development, review, and revision of departmental procedural documents
• Provides training for DM staff
• Evaluates departmental practices with a focus on continual process improvement from a analytical and data quality stand point
• Participates in evaluation and application of DM resource allocation
• Oversees project EDC releases to ensure release requirements are met (standard reports, alert management, site and user activation and training, DM data review tools etc.)
• Other duties assigned by Director, Information Data Management

Oversee the implementation of the following activities on a project basis:

• Define eCRF specs from a protocol
• Build eCRFs in EDC
• Define and build data set specs
• Define edit checks/validation specs
• Write and execute data management plans
• Clean and query data, and manage site/CRA follow up
• Manage reconciliations with external data such as labs and IRT
• Define listings and reports for technical staff in terms of clinical data set variables
• Development of DM project activities timelines
• Preparation and maintenance of action item logs for DM projects
• Development and delivery in data sets in SDTM format
• Advocate for greater use of dynamic graph viewer in protocol compliance, data review, and cleaning activities
• Maintain awareness of and implement best industry practices per SCDM good clinical data management practices

Requirements

• Bachelors degree preferably in the sciences
• At least 5 years experience leading DM projects
• Minimum of 10 years experience in clinical research as a Clinical Data Manager or Clinical Research Associate
• Direct experience with hands on building EDC and validation check configurations
• Great communications skills, both verbal and written, remotely and in-person
• Organized and detail-oriented for improving data management processes
• Ability to work as a team for organizational success.

Education and Experience

Bachelor’s degree. Experience in clinical research, biotechnology and/or healthcare industry required. Experience with the following eClinical product areas: Data Integrations, Data Analytics, eDC, Safety, eTMF, RTSM/IxRS, CTMS, or Investigator Grant Management. Proficiency with Microsoft Office Tools (Excel-Spreadsheets, Word, PowerPoint).

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

Ethics – Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Customer Service – Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; ensures the IDM team is meeting project commitments.

Teamwork – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone’s efforts to succeed.

Professionalism – Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.

Work Environment – This job is based out of our headquarters in Philadelphia, PA but will be a remote position.

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

This is an equal employment opportunity and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.

We are looking for a detail-oriented Clinical Research Proposal Specialist with prior experience in the life sciences industry, who possess excellent time management and communication skills to assist our Business Operations department in keeping up with the fast-paced environment that comes with the technology and life science industries.

Essential Duties and Responsibilities

• Utilize Excel and other provided tools to process reconciliations, change orders, BAU reports, budgets, and write proposals.
• Review RFPs (Request for Proposal); develop necessary budget assumptions from study protocols/synopses; and identify and resolve any questions that are needed to prepare a proposal.
• Participate in pre-RFP client/prospect meetings.
• Create competitive quotes based on the RFP
• Work with Business Operations, Medical and Operational personnel to develop effective proposals, including scopes of work, project assumptions, and budgets.
• Review and revise proposal content as needed to ensure a clear, compelling strategy to execute the trial is articulated.
• Creating and negotiating budgets.
• Present proposals to clients and prospects.
• Participate in client/prospect discussions and requests for information following delivery of proposal.
• Assist in the enhancement of tools and processes, as well as keeping up to date on industry norms and advances.
• Conducts qualitative and quantitative research to create customized and compelling business development documents focused on client solutions that highlight company differentiation, innovation, and operational strategy.
• Produces high quality, customer-specific deliverables.
• Ensures effective communication among internal stakeholders throughout the process so that the strategy drives the project and the final documents achieves its goals.
• Meets deadlines consistently by establishing priorities and target dates for document contributions, review, and approval by key stakeholders including executive leadership.

Qualifications

To perform this job successfully, an individual must have prior experience in performing each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

• Minimum of a bachelor’s degree with a major in finance, accounting, business administration, business management, project or operations management, or another related field.
• Demonstrated proficiency with all Microsoft Office Tools.
• Must have advanced skills in Excel
• Excellent interpersonal and teamwork skills are imperative.
• Excellent time management.
• Must have strong customer service orientation and be a proactive and effective communicator.

Language Skills – Possess the ability to communicate and comprehend written and oral instructions. Able to effectively present information and respond to questions from colleagues and customers.

Reasoning Ability – Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Able to apply common sense solutions towards the execution of responsibilities.

Work Environment – This job is based out of our headquarters in Philadelphia, PA and is to be performed in the office.

Other – As provided by the Americans with Disabilities Act, the company is committed to discussing and providing reasonable accommodations to its employees to help them fulfill the essential functions of their jobs.

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

This is an equal employment opportunity and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.

This is an entry level position.

Our ideal candidate is a professional to perform well in a team environment in the two most lucrative industries, healthcare and technology.

Responsibilities

• Update and keep records
• Research and qualify companies
• Provide troubleshooting assistance
• Stay up-to-date review project records
• Provide data to help the Business Operations
• Manage tracking tools and report on important information
• Liaise with accounts
• Be process oriented
• Competitor research
• Provide data to support your colleagues

Do your interests include?…

• Teamwork
• Working alongside high achieving colleagues
• Work that appeals to your numbers skills

Prevail InfoWorks is a great workplace for anyone, with unique advantages for those just starting out their career. We have had great success giving students and recent graduates opportunities with our company.

This job is based in our Philadelphia, PA headquarters. Job will be performed in office.

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

This is an equal employment opportunity and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.