Sunday, June 6, 2010

[CNG] Digest Number 1998

Messages In This Digest (5 Messages)

1a.: Local to Bridgeport, CT - Volunteer Opportunity From: Keith Bogen SPHR
1b.: Local to Bridgeport, CT - Volunteer Opportunity From: Keith Bogen SPHR

2.: FREE Event on June 9 @ Rutgers - "Get a Life, Not a Job" From: Ann Garvey

3.: FW: NJ IIBA June 17 Chapter Meeting - BA Careers From: Ann Bergquist

4.: Device and Pharmacovigillance Manager in Ft. Washington PA From: Keith Bogen SPHR

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1a.: Local to Bridgeport, CT - Volunteer Opportunity

Posted by: "Keith Bogen SPHR" keith.bogen@yahoo.com hrslugger2002

Sat Jun 5, 2010 7:56 am (PDT)

A non-profit in Bridgeport, CT is looking for L&D and HR Practitioners who are willing to donate some time and expertise! Potential topics are skills inventory/assessment for talent management program, some administrative HR assistance for coordinating internship and volunteer and programs, supervisory/management training, communication (respect/internal customer service) training, time management training, and other potential areas… If you are an expert in something, and willing to volunteer your time in Bridgeport for a very worthy cause, please let me know! You can email me directly at jscott@hireeffect.com, or comment here.

Thanks!

Jennifer M. Scott
HR Consultant, Recruiter, Coach
www.HireEffect.com
Tel: 203-968-9969 ¨Fax: 928-569-9969 ¨Skype: JS.HireEffect

http://www.linkedin.com/in/jenniferscott
http://hireeffect.blogspot.com/
http://twitter.com/HireEffect
http://www.facebook.com/jennifer.pashkin.scott
http://companies.to/hireeffect

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1b.: Local to Bridgeport, CT - Volunteer Opportunity

Posted by: "Keith Bogen SPHR" keith.bogen@yahoo.com hrslugger2002

Sat Jun 5, 2010 7:56 am (PDT)

A non-profit in Bridgeport, CT is looking for L&D and HR Practitioners who are willing to donate some time and expertise! Potential topics are skills inventory/assessment for talent management program, some administrative HR assistance for coordinating internship and volunteer and programs, supervisory/management training, communication (respect/internal customer service) training, time management training, and other potential areas… If you are an expert in something, and willing to volunteer your time in Bridgeport for a very worthy cause, please let me know! You can email me directly at jscott@hireeffect.com, or comment here.

Thanks!

Jennifer M. Scott
HR Consultant, Recruiter, Coach
www.HireEffect.com
Tel: 203-968-9969 ¨Fax: 928-569-9969 ¨Skype: JS.HireEffect

http://www.linkedin.com/in/jenniferscott
http://hireeffect.blogspot.com/
http://twitter.com/HireEffect
http://www.facebook.com/jennifer.pashkin.scott
http://companies.to/hireeffect

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2.: FREE Event on June 9 @ Rutgers - "Get a Life, Not a Job"

Posted by: "Ann Garvey" agarvey44@yahoo.com ann_garvey

Sat Jun 5, 2010 3:22 pm (PDT)

Hello Everyone,

I thought this might be of interest...

Kind Regards,
Ann Garvey, PMP
http://www.linkedin.com/in/anngarvey
732-580-7184

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3.: FW: NJ IIBA June 17 Chapter Meeting - BA Careers

Posted by: "Ann Bergquist" annber55@yahoo.com annber55

Sat Jun 5, 2010 6:58 pm (PDT)

Thursday 6/17 5:30 Madison, NJ - A great group!

Career Forum Jointly Sponsored by
IIBA NJ Chapter and FDU Graduate Business Club

From Ann Bergquist
http://www.linkedin.com/in/annbergquist

New Jersey IIBA June Chapter Meeting

Where:Fairleigh Dickinson University
Lenfell Hall in "The Mansion"
285 Madison Avenue
Madison, NJ

Driving Directions

When:
June 17, 2010 at 05:30 PM
-to-
June 17, 2010 at 08:00 PM
Add to my calendar

Career Forum Jointly Sponsored by
IIBA NJ Chapter and FDU Graduate Business Club

Attend the June 17th Chapter meeting and meet our panelists who will be discussion BA Careers.

Eli Amdur
Sharon Ashton
Slex Freund
Peter Johnson
Bill Musman
Topics covered by the panel will include

Self-assessment / Self-documentation
Search techniques
Interview and negotiations techniques
Career continuity
Business analyst career path and career options.

We will also have recruiters so bring copies of your resume. You will have an opportunity to netword from 5:30pm - 6:00pm and 7:30pm - 8:00pm.

Directions and Parking - note that on the map the Mansion is right in the middle. Parking is noted in blue.

Mansion Directions & Parking

Register Now!

If you are a member, select 'Member' and 'Pay at the Door' you will not be charged a fee.

Non-members may pay $15 via PayPal when registering or may pay at the door - cash or check only.

Forward email

This email was sent to annber@hotmail.com by lindafitzgerald@hotmail.com.
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Email Marketing by
New Jersey IIBA Chapter | 15 Mtn View Rd | Warren | NJ | 07876

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4.: Device and Pharmacovigillance Manager in Ft. Washington PA

Posted by: "Keith Bogen SPHR" keith.bogen@yahoo.com hrslugger2002

Sat Jun 5, 2010 9:04 pm (PDT)

Are you looking for a new opportunity? I am looking for a Device and Pharmacovigilance Alliance Manager for a just released opening located in FORT WASHINGTON, PA! This position is with a Reputable Pharmaceutical Company, a Six Months term contract with the possibility of being extended. The job Description is below.

If you are qualified, available, interested, planning to make a change, or know of a friend who might have the required qualifications and interest, please email ASAP, even if we have spoken recently about a different position. Please include a daytime phone number so I can reach you. In considering candidates, time is of the essence, so please respond ASAP.

**Don't wait - this position will be filled quickly.

Thank You,

Elizabeth Lizardo
elizabeth.lizardo@acsicorp.com

JOB DESCRIPTION

Position Summary
This position is responsible for the executive management of 3rd Party Device- and Pharmacovigilance (D&Pv) Partnerships/Alliances relevant to the Pharmaceutical Consumer companies; collaborates with the Senior Leadership of Pharmaceutical Consumer Companies and BRM to ensure end-to-end partnering with the 3rd Party on Product D&Pv; takes appropriate action in case of D&Pv Alliance issues and, in collaboration with the Head PAM, decides the escalation path.
This position leads the complete process around 3rd Party – Pharmaceutical Consumer relevant D&Pv Agreements (initial and renewals) and conducts negotiations with the 3rd Party. Ensures Pv Agreements are executable and compliant with all applicable Law and Regulations. Collaborates in this effort with BRM Legal Counsel, appropriate Pharmaceutical Consumer and BRM Functions.
Upon request from Pharmaceutical Consumer Business Development, this position will participate on D&Pv in Due Diligence efforts. Where appropriate, he/she liaises with Chief Safety Officer Consumer, the EEA QPPV Consumer and other relevant stakeholders in Pharmaceutical Operating Companies.

Principal Responsibilities:

Executive management of the Pharmaceutical Consumer-related D&Pv Partnerships/ Alliances. In collaboration with Pharmaceutical Consumer and BRM Senior Leadership:
• Where applicable, based on the D&Pv Agreements, provide directions and advice to BRM functional representatives who handle the operational and technical issues on a daily basis
• work with all stakeholders, including but not limited to Consumer Center for Product Quality, Consumer Office Safety and Technology to ensure end-to-end management and safety oversight of mixed product quality and adverse event or device safety reports
• determine the Product Integration path; prepare a draft Transfer Plan
• determine need for a product Safety Oversight Working Group; prepare set-up with Partner and Company representation, if applicable
• monitor the Alliance; in case of issues take appropriate action and, in collaboration with Head PAM, determine escalation path
• monitor resolution of mutually agreed corrective actions

Further:
• develop controlled process documents (SOP) for Pharmaceutical Consumer Operating Companies to manage contractual aspects of D&Pv for all relevant agreements between Operating Companies and 3rd Parties
• develop and maintain appropriate D&Pv Agreement template text

Team leader for Pv Agreements; partnering with Legal Counsel, global/regional Business Development and Marketing Partners of the Pharmaceutical Consumer business:
• ensure BRM functional buy in to the terms of a prospective D&Pv Agreement; determine the appropriate, named functional contacts
• ensure the final D&Pv Agreement is both executable and compliant with applicable Law and regulations
• implement the timely revision of existing D&Pv Agreements of Pharmaceutical Consumer Operating Companies with 3rd parties

Upon request from Pharmaceutical Consumer Business Development, participate in Due Diligence (L&A, M&A) efforts; evaluate the D&Pv process and Product Safety components of global /regional product and/or company licensing and/or acquisition opportunities:
• Contribute to the relevant sections of Due Diligence Report; i.e. the PV organization; documentation of procedures; information management; case processing; signaling; single case and aggregate reporting; labeling; audits/inspections; and, any program specific issues
• Where appropriate, ensure that known/suspect Safety Issues emerging from the Due Diligence are communicated appropriately to the initiating Pharmaceutical Consumer Companies, the Consumer Chief Safety Officer and, where applicable, to the EEA QPPV - Consumer
• Where appropriate, conduct research to deliver Product Adverse Event Volume/Workload Estimates as input to the draft Transfer Plan for BRM

Decision Making Responsibilities
• Works within matrix BRM, Pharmaceutical Consumer Office of Safety and Technology and 3rd Party teams to ensure that the Product Safety and D&Pv-relevant exchanges in the Alliance are consistent with the terms of the Pv Agreement. Where necessary, initiates unscheduled review of the Pv Agreement.
• Applies the appropriate tools to monitor D&Pv Alliances/Partnerships and takes action where (potential) issues might arise. Escalates, applying judgment; goal is to optimize and sustain Alliances with the minimal necessary resources.
• Recommends to the BRM Senior Leadership decisions regarding BRM commitments in contractual agreements supporting Products marketed by Pharmaceutical Consumer Companies. To be taken into account are applicable Law and Regulations, BRM resources, policies and internal company standards

Education and Experience Requirements
• A minimum of a Bachelor's degree is required (graduate level highly preferred) in a relevant discipline; Medical, or additional Business or Legal qualification is of interest
• Applied knowledge of applicable Law and Regulations governing Pharmacovigilance and Device Safety Reporting on global level
• Working experience in a drug safety organization at a significant level of operational responsibilities
• Ability to communicate clearly and concisely in verbal and written form
• Excellent negotiation and networking skills
• Demonstrated problem solving ability
• Demonstrated ability to lead, and generally to excel working in matrix teams
.........................
Thanks again.
Elizabeth Lizardo
elizabeth.lizardo@acsicorp.com

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