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Sr Manager, Drug Safety. Job in Cambridge, Massachusetts, United States in Biogen. Nelest.com
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Sr Manager, Drug Safety

col-narrow-left   

Job ID:

23094

Location:

Cambridge, MA 

Job function:

Business Development, Project Management
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Sr Manager, Drug Safety

Job Description:

The Senior Manager, Safety Data Collection (Post-Marketing) is responsible for managing the Pharmacovigilance (PV) operations for the safety data collection in the Post-Marketing space (non-clinical) globally. The employee supports the Associate Director, Safety Data Collection (Post-Marketing) and is responsible for setting the safety operation strategy, establishing the safety report collection standards and processes, and ensuring they are implemented and executed consistently throughout the Post-Marketing space (non-clinical) globally. The Senior Manager, Safety Data Collection (Post-marketing) will provide partner / vendor oversight in relation to Post-Marketing safety report collection and will collaborate with other Biogen functions (e.g., Commercial and Global Medical) to ensure consistency with regulations and with departmental goals and objectives.

1. Support the Associate Director, Safety Data Collection-Postmarketing with setting the safety operations strategy and establishing the safety report collection standards and processes for the collection of Post-Marketing (non-clinical) safety reports from all sources globally
2. Execute the development, maintenance and implementation of:
a. Controlled documents (SOPs), data handling conventions and other process documents for safety report collection
b. Safety operational content and processes for tools for Post-Marketing safety report collection such as AE forms and electronic data capture system
c. Database requirements and configurations to enable safety-related activities
d. Training requirements and materials for Post-Marketing safety report collection
e. Report metrics and KPIs for Post-Marketing safety report collection
3. Oversee the gathering of Post-Marketing safety reports from all sources globally
4. Support the following partner / vendor oversight activities, in conjunction with relevant functions (such as Global Medical and Commercial), in relation to Post-Marketing safety report collection:
a. Provide functional support / input to set up partner and vendor relationship (e.g., business requirements, vendor selection, contract details, vendor oversight plans)
b. Support onboarding and ongoing maintenance of partner and vendor status to perform work (e.g., access, training, technology set-up)
c. Provide ongoing support of partners and vendors (e.g., questions, issues, meetings)
d. Conduct partner oversight and performance management on AE intake work (e.g., monitoring reports, quality evaluations, annual meetings)
5. Communicates on PV legislation and regulatory commitments across the organization and externally

*LI-RD2

Job Requirements:

Qualifications
- 5+ years in drug safety/Pharmacovigilance in pharmaceutical industry setting or the equivalent.
- Experience interacting with third parties with PV / AE intake responsibilities (e.g., vendors acting as call centers) required
- Knowledgeable in Pharmacovigilance and GCP legislation required
- Direct experience in GXP compliant quality systems preferred
- Excellent written and verbal communication skills including: technical writing skills, PC skills, ability to produce clear, concise documentation and good analytical skills
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization
- Effective managerial skills, being a self-starter, ability to work independently, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritize
- Ability for individual decision-making required
- Must demonstrate initiative to identify and communicate issues within department and across departments Education
- Minimum of Bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required
- Master's or Doctorate level degree in health care related profession preferred About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

Zip Code:

02142

Company Info
Biogen

Cambridge, MA, United States

Phone: +1 781-464-3260, +1 781-464-3260
Web Site: www.biogene.com

Company Profile

Company Info


Biogen
Cambridge, MA, United States
Phone: +1 781-464-3260, +1 781-464-3260
Web Site: www.biogene.com

Sr Manager, Drug Safety

col-narrow-left   

Job ID:

23094

Location:

Cambridge, MA 

Job function:

Business Development, Project Management
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Sr Manager, Drug Safety

Job Description:

The Senior Manager, Safety Data Collection (Post-Marketing) is responsible for managing the Pharmacovigilance (PV) operations for the safety data collection in the Post-Marketing space (non-clinical) globally. The employee supports the Associate Director, Safety Data Collection (Post-Marketing) and is responsible for setting the safety operation strategy, establishing the safety report collection standards and processes, and ensuring they are implemented and executed consistently throughout the Post-Marketing space (non-clinical) globally. The Senior Manager, Safety Data Collection (Post-marketing) will provide partner / vendor oversight in relation to Post-Marketing safety report collection and will collaborate with other Biogen functions (e.g., Commercial and Global Medical) to ensure consistency with regulations and with departmental goals and objectives.

1. Support the Associate Director, Safety Data Collection-Postmarketing with setting the safety operations strategy and establishing the safety report collection standards and processes for the collection of Post-Marketing (non-clinical) safety reports from all sources globally
2. Execute the development, maintenance and implementation of:
a. Controlled documents (SOPs), data handling conventions and other process documents for safety report collection
b. Safety operational content and processes for tools for Post-Marketing safety report collection such as AE forms and electronic data capture system
c. Database requirements and configurations to enable safety-related activities
d. Training requirements and materials for Post-Marketing safety report collection
e. Report metrics and KPIs for Post-Marketing safety report collection
3. Oversee the gathering of Post-Marketing safety reports from all sources globally
4. Support the following partner / vendor oversight activities, in conjunction with relevant functions (such as Global Medical and Commercial), in relation to Post-Marketing safety report collection:
a. Provide functional support / input to set up partner and vendor relationship (e.g., business requirements, vendor selection, contract details, vendor oversight plans)
b. Support onboarding and ongoing maintenance of partner and vendor status to perform work (e.g., access, training, technology set-up)
c. Provide ongoing support of partners and vendors (e.g., questions, issues, meetings)
d. Conduct partner oversight and performance management on AE intake work (e.g., monitoring reports, quality evaluations, annual meetings)
5. Communicates on PV legislation and regulatory commitments across the organization and externally

*LI-RD2

Job Requirements:

Qualifications
- 5+ years in drug safety/Pharmacovigilance in pharmaceutical industry setting or the equivalent.
- Experience interacting with third parties with PV / AE intake responsibilities (e.g., vendors acting as call centers) required
- Knowledgeable in Pharmacovigilance and GCP legislation required
- Direct experience in GXP compliant quality systems preferred
- Excellent written and verbal communication skills including: technical writing skills, PC skills, ability to produce clear, concise documentation and good analytical skills
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization
- Effective managerial skills, being a self-starter, ability to work independently, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritize
- Ability for individual decision-making required
- Must demonstrate initiative to identify and communicate issues within department and across departments Education
- Minimum of Bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required
- Master's or Doctorate level degree in health care related profession preferred About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

Zip Code:

02142
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