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    Solution Of The Year


Safety Systems Analyst/ Drug Safety
Florham Park, NJ
6 months (at least) contract extendable.
This position is more IT focused and hence we need someone very savvy with Argus Safety Database with Excel pivot table experience, Argus, aggregate reporting analysis, and health care professional degree.
The Safety Systems Analyst will be part of the Drug Safety team and will assist the Manager of Safety Systems with systems-related activities for the safety operations team as well as other areas of safety including aggregate reports, signal detection, and database systems support. The analyst will be responsible for providing technical expertise on safety systems, specifically the Argus safety database.
DUTIES AND RESPONSIBILITIES include, but are not limited to, the following:
• Collaborate with the database hosting vendor to develop system changes/plans and to implement these changes/plans as needed to support Drug Safety business needs.
• Organize, track, and implement database change control requests including, but not limited to, product configuration, protocol configuration, user access changes, etc. as per procedures. Ensure system users are appropriately trained on database updates.
• Provide solutions for database requests received from system users (e.g., enhancement, new functionality requests, and troubleshooting).
• Create and deliver standardized/consistent/accurate data retrievals from the safety database, both routine monthly reports and/or ad hoc queries, as requested by internal and external customers.
• Generate accurate tables, figures, and/or listings for aggregate reports (e.g., periodic reports, PBRERs), signal detection activities, inspections/audits, and ad-hoc reports.
• Draft US PADER reports, including supporting data.
• Setup and troubleshoot E2B reporting. Review and track acknowledgement messages.
• Participate in the implementation and testing of database change control requests or upgrades, which may include testing changes in the development environment and/or preparation and execution of validation test scripts.
• Analyst may be required to write, review and/or execute such test scripts. Analyst will support the execution and documentation of updates to user and functional requirement specifications as well.
• Organize data using Excel to create tables and charts to facilitate data analysis for aggregate data review as well as for signaling activities.
• Provide database training to Drug Safety staff on all safety systems related functions and when appropriate, provide job-specific training to end users.
• Maintain database user guide and safety system training materials.
• Work with database hosting vendor to ensure timely responses on Shionogi’s open incidents in accordance with work order(s)/service agreements.
• Maintain and support Ovid auto-alerts for searching the global literature for adverse event reports.
• Contribute to process improvements related to the safety database.
• Participate in other projects as assigned.
• Bachelor’s degree in life sciences, computer science, or health-related field required. (RN, RPH or PharmD is a plus).
• At least 3 to 4 years of experience supporting a Drug Safety database in a pharmaceutical company, or equivalent.
• Must have extensive experience working with standard safety software, specifically, Argus Safety.
• Requires strong knowledge of pharmacovigilance terminology and practices as well as the Argus safety database. The incumbent should possess excellent technical, analytical, and problem –solving skills related to safety database systems.
• Should have hands-on experience with the following: implementing Argus upgrades/new functionality; writing/running/reviewing validation test scripts; change control requests/testing/implementation; setup of electronic reporting to Regulatory Authorities; querying the database for safety-specific information/generating advanced conditions/running SMQ searches; experience generating aggregate reports/listings utilizing the safety database capabilities; performing electronic submissions.
• Strong working knowledge of pharmacovigilance regulations and MedDRA coding is required.
To apply please email your resumes at info@clinronllc.com

Job Title: Drug Safety Associate (Contract Position)
Department: Corporate Drug Safety and Pharmacoepidemiology (CDSP)
Reports to: Senior Manager, Drug Safety
Prepared Date: 24-May-2016
The occupant of this CONTRACT position supportsDrug Safety and Pharmacoepidemiology United States (DSPUS) with the collection and processing of individual case safety reports (ICSRs) associated with the use of Braccomedicinal products and medical device reports (MDRs) from all sources (post-marketing, clinical trial, literature, etc.). He/she is also responsible for preparing case files and tracking the necessary workflow steps in order to ensure compliance with internal deadlines and external regulatory reporting timeframes.
1. Support DSPUS with the collection, review, and quality control (QC) check of adverse event data entered in the Bracco Global Safety Database in order to ensure compliance with Good Pharmacovigilance Practices and regulatory reporting regulations.
2. Continuously monitor the DSPUS Adverse Event electronic mailbox for the receipt of new information.
3. Distribute incoming e-mails to the appropriate Monitor.
4. Establish casefiles for newly-received ICSRs/MDRs.
5. Enter ICSRs/MDRs into the Drug Safety database (ClinTrace).
6. Write standard Narratives based on the adverse event information received.
7. Code adverse event terminology using standard dictionaries (MedDRA and WHO-Drug).
8. PerformQC checks for ICSRs received in the form of line listings and/or entered by other DSPUS staff.
9. Track various adverse event workflow steps (receiving, distribution, reporting, etc.) in the DSPUS tracking system (DARWIN-US) in order to monitor compliance with internal and regulatory deadlines.
10. Distribute ICSRs/MDRs to ROW Affiliates/Distributors within the appropriate timeframes.
11. Assist with resolution of issues/data consistency errors pertaining to pharmacovigilance data.

1. Assist with serious adverse event (SAE) reconciliation.
2. Interact with other DSPUS and Drug Safety and Pharmacoepidemiology Europe (DSPE) staff to perform other duties, as needed.
3. Perform other CDSP functions, when necessary.

• None

CORE COMPETENCIES: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the core competencies required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Excellent oral and written English communications skills.
• Knowledge of regional and international regulations pertaining to pre-marketing and post-marketing safety and surveillance and medical device reporting.
• Excellent computer skills including Microsoft Office (WORD, EXCEL, POWERPOINT, etc.).
• High level of precision and accuracy.
• Demonstrated cooperation and teamwork skills.

• Degree in life sciences, medicine, pharmacy, or nursing preferred.
• A minimum of one (1) to two (2) years Drug Safety experience in a pharmaceutical, biotech, or CRO company.
• Thorough knowledge of medical terminology and MedDRA coding.
• Prior experience with drug safety databases (ClinTrace, Argus, etc.).
• Previous medical device experience is a plus.

Not required.

PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The employee must have excellent oral and written communication skills in order to perform the essential duties of this position.
• The employee will need to sit for long periods of time working with a computer.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Standard office environment assumed.
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• The position is office based and does not allow working from home.

• Daily interaction with other BDI DSP staff.
• Interaction with personnel from other BDI departments including Professional Services, Quality, Regulatory, and Sales Representatives.
• Support the Legal department as required.

To apply please email your resumes at info@clinronllc.com

Clinical Trial Assistant

Gaithersburg, MD

12-36 months

We are looking for coordinator candidates with either Clinical Trial experience. They do not necessarily need to come from Pharma or Bio Tech although this is a nice to have. They do need to understand the clinical space and must work well with others.

Co-ordination of projects involving initiation and implementation activities while keeping to time management, cost and specification.
• BA or BS degree with preferred major in business, marketing, communications or a related field
• 1-3 years of proven experience successfully coordinating initiatives and delivering timely results for corporations and/or nonprofit organizations
• Excellent written (for exceptional business communications as well as editing/proofreading) and oral presentation skills
• Proficient in all applications of MS Office (strong emphasis on Word, Excel, and PowerPoint) and SharePoint
• Excellent organizational skills with the ability to prioritize multiple projects and meet deadlines
• Process-driven, to perform daily tasks, with the dual capability of being flexible to perform in an evolving environment
• Strong attention to detail and commitment to deliver quality results
• History of successful interpersonal communication within the workplace
• Demonstrated ability to work independently as well as in a team atmosphere

To apply please email your resumes at info@clinronllc.com

Regulatory Affairs Specialist

Job Description:

Assists in planning, review and preparation of CMC (chemistry, manufacturing and control) components of investigational new drugs, new biologic license applications and related progress reports, amendments, supplemental applications, and continued maintenance of approved marketed products. Work across functional groups and program teams, propose strategies and solutions. Coordinates and manages CMC change control systems and related databases for clinical and commercial applications. Ensures compliance with regulatory authority regulations and interpretations. Opportunities to interact with regulatory agency personnel.

Essential Functions

1. Assist in the technical review and preparation of various investigational drug, marketing applications and other formal reports for submission to regulatory agencies – 30%
2. Ensure that the content and structure of documents meet established regulatory requirements – 15%
3. Liaise as CMC representative across functional groups, program teams, international regulatory groups and business partners, propose strategies and solutions at level of personal technical experience and identify issues that may delay project timelines – 15%
4. Maintain Regulatory CMC documentation – 15%
5. Track CMC process changes in form of change control system, maintain related databases and submission schedules – 15%
6. Assist in developing submission plans, strategies and project timelines – 5%
7. Assist in the preparation and interactions with regulatory agencies regarding drug submissions, responding to inquiries and during regulatory agency inspections – 5%

Education & Experience Requirements

BS/MS in scientific discipline, plus minimum 2 plus years of relevant pharmaceutical industry experience, plus a minimum of 0-2 years of relevant experience in regulatory affairs

Key Skills and Competencies

Incumbents at this level are involved in relatively routine tasks of moderate scope and complexity. Applicant will need a strong understanding of pharmaceutical/drug manufacturing in terms of development, manufacturing and quality. Will need to learn an understanding of related federal regulations and guidance’s.

Other Job Components
Complexity and Problem Solving

Work is performed under close supervision. Receives general instructions on routine work and detailed instructions on new work assignments. Exercises judgment within defined procedures and practices to determine appropriate action.
Internal and External Contacts

Contacts are primarily with immediate supervisor, project leaders and other members in the department or project team.

To apply please email your resumes at info@clinronllc.com

Quality Manager

Job Description:

Provide subject matter expertise and accountability for Shire Quality Risk Management (QRM) Program, which includes the following actions; (50%)

• Provide QRM (ICH Q9 and ISO-14971) guidance and support to various cross-functional organizations.
• Facilitate risk analysis (FMEA, FMECA, PHA, HACCP and other equivalent accepted methods).
• Analyzes data from various sources (including, but not limited to: Non-Conformances, CAPAs, Deviations, Complaints, etc.) to identify and initiate QRM opportunities.
• Escalate critical risks identified during risk assessments to management.
• Perform Risk Analysis activities to ensure process and product shortcomings are identified and appropriately addressed.
(10 – 15%)
• Educate and train appropriate Shire personnel on quality risk management practices and associated risk documentation requirements.
(10 – 15%)
Maintain Shire’s Risk Register process

• Coordinate the input process for new risks added into the Risk Register.
• Create periodic (monthly) management reports highlighting critical risk register events.
• Verify activity status of risk register events for closure with appropriate risk action owners.
• Escalate critical risk events to Management (immediate supervisor and others)
(5 – 10%)
• Create Quality Risk Management standard operating procedures, such as; FMEA, PHA, HACCP, PHA, etc. as required.
• Participate in regulatory agency inspections for Quality Risk Management initiatives.
• Author and review responses to inspection observations and agency questions pertaining to QRM.
• Identify opportunities for continuous improvements and enhancement of Shire QRM program to reflect current regulations and industry trends.

To apply please email your resumes at info@clinronllc.com

Drug Safety Associate

The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job.

Job Description

• Assist with the overall Clinical Safety and/or PV&DSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports).
• Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.
• Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
• He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.

Essential Job Duties:
Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:

• Entry of Safety data onto adverse event databases and tracking systems.
• Review of adverse events for completeness, accuracy and appropriateness for expedited reporting.
• Write patient narratives
• Code adverse events accurately using MedRa
• Determine expectedness/listedness against appropriate label
• Identifies clinically significant information missing from initial reports and ensures its collection
• Ensure case receives appropriate medical review
• Prepare follow-up correspondence consulting the medical staff accordingly.
• Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines.
• Reporting of end points to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines.


• Non-degree +4-5 yrs relevant experience (or 2 yrs safety experience) *
• Associates Degree+3-4 yrs relevant experience (or 1-2 yrs safety experience) *
• Associate Degree RN+2-3 yrs relevant experience (or 1-2 yrs safety experience) *
• BS/BA+1-2 yrs relevant experience**
• MA/MA+0 yr relevant experience**
• PharmD+0 yr relevant experience**
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences and Chemistry.

*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.

**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.

• High degree of accuracy with attention to detail
• Function as a team player
• Good Communication
• Knowledge of medical and drug terminology desirable
• Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation.
• Familiarity with ICH guidelines
• Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products
• Ability to work independently with moderate supervision
• Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial

To apply please email your resumes at info@clinronllc.com