Careers @ Plenum

Careers @ Plenum

Plenum USA is always looking for GREAT employees: people who want to Grow, who are Responsible, who are Enthusiastic about their work, who are Adaptable in a fast-paced environment, and who are Talented.At Plenum USA, we understand that success of a company is related to its ability to hire and retain personnel at all levels of the business. That's why individuals with high integrity, strong leadership skills and proven track record are in such demand. They bring the qualities to an organization that can positively affect its fortunes.

At Plenum USA, we not only provide our consultants/employees the freedom and independence of working in an open environment but also have the fun of meeting new people, working at new places and facing new challenges every day. We continuously strive in creating a dynamic and challenging work environment that encourages and acknowledges both individual contributions and team efforts. Our compensation structure is rewarding, and our benefit program is competitive.

At Plenum we offer career and not just jobs. We recognize and understand that success of any organization is its employees. That is why we strive to redefine the conventional norms by providing a work environment that is conducive to all-around personality development, where teamwork is as important as individual excellence and achievement. We look at environment,which is result based and performance driven. We believe in continuous training to improve the skills of our employees and help them to perform the most challenging assignment.

Our benefit package is based on competitive industry standards and aims at providing a number of benefits in addition to a base salary. These include:

• Attractive compensation
• All Immigration related issues.
• Comprehensive healthcare coverage for medical care, dental care and vision
• Life Insurance including short-term and long-term disability coverage resulting from sickness/accidents
• Workers compensation insurance covering risks associated with work related injuries and disabilities, both short term and long term in nature
• Financial assistance for training, taking certification courses and skills upgrade
• Standard industry holiday schedules
• Relocation expenses, when moving from one project assignment to the other
• Referral Bonus on providing leads/openings at project

If interested please reply with an updated resume to: plenum@usa.com
Please stop by again for new and exciting opportunity at Plenum.

Drug Safety Officer

The Drug Safety Officer (DSO) is a member of the Drug Safety Department and works within a project team structure. The DSO is primarily responsible for reviewing adverse event (SAE) reports from an assigned project(s), clinical trials (CT) and/or post marketing spontaneous reports. The DSO is responsible for completeness and clarity, defining and initiating follow-up through the appropriate channels, participating in the triage of these reports for regulatory reporting purposes. Demonstrates basic knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements. Demonstrates proficiency in case triage for project molecule and serve as a back-up for additional projects. Identify proper case regulatory reporting requirement and seeks assistance when necessary. Identifies and utilizes resources and support when available for adverse event triage and management. Applies Good Clinical Practices document of phone, electronic, and/or fax correspondence regarding case follow-up per SOP. Competent and performs clinical triage per SOP. Identifies pertinent clinical information in Adverse Event reports and incorporates information in narrative. Identifies triages and /or enters relevant follow up information per SOP. Performs basic searches for data queries within the safety database

Requirements: Basic knowledge of safety concepts, ICH/GCP/SOP and FDA guidelines. RN, BSN, PA, NP, MD, MSN, Pharm D Experience in a Drug/Medical Device industry in the area of Drug Safety.

Computer System Validation/Data Analyst

Computer Validation experience SOP Writing, Documentation with 21 CFR Part 11 experience. Computer system validation the area of manufacturing, laboratory, network and application software. Work with system owners to explain the assessment and remediation plans. Perform gap analysis for Part 11 compliance. Perform Risk Assessment and create compliance deliverables.

Knowledge of FDA cGMP related regulatory guidelines, expertise in computer validation methodologies and principles. Experience in EDC and SAS, Adverse Events, IND Publishing, Laboratory Systems (Chemstation, Turbo chrom, Waters Millennium, Waters LIMS, etc.).

Requirements: Knowledge of FDA and other regulatory authority. Experience in writing, reviewing and executing computer validation documentation (Validation Master Plan, IQ/OQ/PQ, summary report). Excellent communication skills and ability to work as a team members. Will require local travel as a direct and contract positions. Must be willing to work extended hours. Document management expertise plus.