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| Company: |
FirstPro Inc. |
 |
| Job Title: |
Global Safety Dir |
| Job Category: |
Pharmaceutical |
| Job Location: |
CA California - USA |
| Job Ref. Number for your records: |
See Blow |
| Job Description: |
Please use “Ref numbers” (highlighted in red) for positions of interest.
If interested in multiple positions please list both Ref numbers. Also, please attach your CV for qualifying. If you have questions feel free to contact me through one of the methods below.
This communication exist under the strictest levels of confidentiality, and is not divulged to outside parties without the express permission of both parties.
Ref: 50187239-A
Job Title
Global Safety Dir
Basic Qualifications:
Bachelors (science preferred) plus 6 - 8 years of biotech/pharmaceutical experience
Preferred Qualifications:
Masters plus 4 - 6 years of biotech/pharmaceutical experience
Doctoral degree and 3+ years of biotech/pharmaceutical experience
Clinical/medical research experience
Drug safety experience in a biotech/pharmaceutical setting
Previous management and/or mentoring experience (highly desirable)
Job Summary
This is an opportunity for a Director position in the Safety Surveillance (SS) group within Global Safety. This function
Provides proactive safety surveillance across the lifecycle of products.
Role/Purpose:
To provide proactive safety surveillance across the lifecycle of products
Key responsibilities include:
- Generate periodic safety reports for assigned products
- Perform periodic safety data review according to a signal detection strategy and communicate findings to the Global Safety Team (GST) for assigned products
- Monitor medical and scientific literature for published articles relevant to the safety profile for assigned products In consultation with GST members and other subject matter experts, define search criteria, run validated database searches, and analyze data for safety signal assessment In consultation with GST members and other subject matter experts,
- Pan and perform analysis in support of response to regulatory inquiries regarding safety issues
- Support development and execution of risk management plans, risk assessment, and risk communications
- Conduct safety data analysis in support of developing and updating safety sections of regulatory documents, core data sheets and product labels, and response to safety inquiries
- Provide background safety information and pharmacovigilance analysis support in support of developing and updating Investigator Brochures and study protocols When requested
- Provide safety data analysis in support of Data Monitoring Committee and response to inquiries from Ethics committee and Investigators
- Support filing activities, such as development and review of Clinical Summary of Safety (CSS), Risk Management Plans, and post-marketing commitment study proposals
- Support writing and review of safety-related publications
- Independently determine approach to safety assessment for specific assignments
- Independently develop safety surveillance strategy for assigned products
- Perform quality control activities for deliverables produced by other SS staff for the GSTs
- Guide and mentor junior Safety Surveillance (SS) staff members on the GSTs
- Lead efforts to improve processes and increase work efficiency applicable to the SS contributions to the GSTs
- Remain in compliance with active standard processes and procedures
Contribute to training of staff regarding safety surveillance and pharmacovigilance
Ref: 50187168-A
Job Title
Global Safety Dir
Basic Qualifications
· Medical Degree (MD) or international equivalent
· Previous management experience Preferred Qualifications:
· Accredited fellowship or clinical experience in relevant therapeutic area specialty
· Clinical experience, including training
· Previous drug safety, biotech/ pharmaceutical or regulatory agency experience
Job Summary
· This is an opportunity for a Director position in the PBRAM group within Global Safety. The PBRAM group provides continuous assessment, management and timely communication of the benefit/risk profile for all products.
Role/Purpose:
· The Global Safety Officer (GSO) leads by establishing the direction and priorities of the GST and is accountable for all product safety related GST decisions for assigned products
· Key interface between the GST, TAH, AGS Sr. Management, GRA, and other functional areas including Global development
· The GSO supported by the GSSL is responsible for the timely communication of safety recommendations and/or actions from the GST to internal and external stakeholders
· This role leads single projects which can be of moderate or high complexity/scope or multiple projects of lower complexity closely collaborating with the Therapeutic Area Head
Key responsibilities include:
· Lead responses to regulatory enquiries regarding safety, including evaluating the question, assigning responsibility, determining data needs, reviewing, approving and submitting the response
· Develops and supports action plans to evaluate safety concerns, internal review and escalation, risk management strategy, execution, and communication
· Lead development of strategy and creation of product risk management plans including maintenance and updates
· Manages quarterly product safety reviews execution and closure of recommendations
· Accountable for safety content of Global Development Plans
· Contribute to and sign off on DMC and adjudication charters
· Represent AGS at meetings with Regulatory authorities
· Participate in planning, review and sign off of clinical trial safety documents for content (includes CSS, 120 Day safety update, protocol safety sections, CSR#s, ICF#s, study safety monitoring plans, Investigator Brochures)
· Drive and support the development and maintenance of DCSI and CDS safety sections via leadership of the GST
· Provide input to potential in-licensing opportunities, safety interactions, and pharmacovigilance agreement with commercial partners
· Participate in planning, provide strategy and content input, and sign off on aggregate safety reports (e.G. PSURs, ASRs)
· Accountable for identification, assessment, and communication of potential safety signals as leaders of GST pharmacovilance activities
· Responsible for regulatory inspection readiness within functional group
· Manage GST in support of Therapeutic Area Head ensuring workload/resource planning
Collaborate, review and sign off SOPs, Business Practices, and Training Manuals as necessary
Ref: 65510138-A
Job Title
Sir .Dir Global Safety
Basic Qualifications
· Medical Degree (MD) or international equivalent
Preferred Qualifications:
· Accredited fellowship or clinical experience in relevant therapeutic area specialty (Inflammation)
· Clinical experience, including training
· Previous drug safety, biotech/pharmaceutical or regulatory agency experience
Job Summary
Role/Purpose:
· The Global Safety Officer (GSO) leads by establishing the direction and priorities of the GST and is accountable for
All product safety related GST decisions for assigned products
· Key interface between the GST, TAH, AGS Sr. Management, GRA, and other functional areas including
Global development.
· The GSO supported by the GSSL is responsible for the timely communication of safety recommendations and/or
Actions from the GST to internal and external stakeholders.
· This role leads single projects which can be of moderate or high complexity / scope or multiple projects of lower
Complexity closely collaborating with the Therapeutic Area head
Job Description:
· Lead responses to regulatory enquiries regarding safety, including evaluating the question, assigning responsibility,
Determining data needs, reviewing, approving and submitting the response
· Develops and supports action plans to evaluate safety concerns, internal review and escalation, risk management
Strategy, execution, and communication.
· Lead development of strategy and creation of product risk management plans including maintenance and updates.
· Manages quarterly product safety reviews execution and closure of recommendations
· Accountable for safety content of Global Development Plans
· Contribute to and sign off on DMC and adjudication charters
· Represent AGS at meetings with Regulatory authorities
· Participate in planning, review and sign off of clinical trial safety documents for content (includes CSS, 120 Day
· safety update, protocol safety sections, CSRs, ICF#s, study safety monitoring plans, Investigator Brochures)
· Drive and support the development & maintenance of DCSI and CDS safety sections via leadership of the GST
· Provide input to potential in-licensing opportunities, safety interactions, and pharmacovigilance agreements with commercial partners
· Participate in planning, provide strategy and content input, and sign off on aggregate safety reports (e.G. PSURs, ASR#s)
· Accountable for identification, assessment, and communication of potential safety signals as leader of GST pharmacovigilance activities
· Responsible for regulatory inspection readiness within functional group
· Manage GST in support of Therapeutic Area Head ensuring workload/resource planning
· Collaborate, Review and sign off SOPs, business practices, and Training Manuals as necessary
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| Skills Required: |
Please look at each discription |
| Language Requirements: |
English-GoodOther: Multiple Languages is never a bad thing.
|
| Employment Type: |
Full Time
|
| Yearly Salary: |
220 USD
|
| Posting Date: |
Apr 18 2008 |
| Education level required: |
Doctorate
|
| Experience (in years): |
3 to 5 Years |
| Job also available in: |
Bay Area, &
Southern California |
| Company: |
FirstPro Inc. |
| Contact Name: |
FirstPro Inc. |
| Contact Phone: |
678-510-7412 |
| Contact Fax: |
404-250-1780 |
| Preferred Method of Contact: |
No Preference |
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