Query SELECT `session_id` FROM `user_session_data_storage` WHERE `session_id` = ? : 
Statement could not be executed (HY000 - 145 - Table './db05/user_session_data_storage' is marked as crashed and should be repaired)
Query INSERT INTO `user_session_data_storage` SET `last_activity` = NOW(), `session_id` = ? : 
Statement could not be executed (HY000 - 145 - Table './db05/user_session_data_storage' is marked as crashed and should be repaired)
Associate Director, Aggregate Reports - Drug Safety. Job in Cambridge, Massachusetts, United States in Biogen. Nelest.com
Home  |  Contact  |  About Us
|   Register  |  Sign In

Associate Director, Aggregate Reports - Drug Safety

col-narrow-left   

Job ID:

23091

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:

Associate Director, Aggregate Reports - Drug Safety

Job Description:

Associate Director Aggregate Reports will be in charge of establishing and leading a team of PV Scientists responsible for aggregate reports for investigational and post-marketing products (i.e., DSURs, PBRERs, RMPs).

The Associate Director Aggregate Reports is responsible for the following:

- Ensuring the necessary resources are available for planned and potentially ad hoc aggregate reports to ensure high quality, timely deliverables.

- Developing processes for aggregate reports that are compliant and meet relevant regulatory requirements, including aggregate report calendar / scheduling, writing, tracking, timeliness and quality.

- Hiring, training, mentoring and managing PV Scientist staff for aggregate report management

- Maintaining compliance with relevant regulatory requirements and implement corrective or preventive actions if non-compliance or potential non-compliance is identified

- Serving as Subject Matter Expert on aggregate report requirements and strategy within PV Scientist team, for SABR and cross-functionally

- Ensure aggregate report data outputs, database queries and data conventions are consistent with the needs of aggregate reports and meet relevant regulatory requirements

- Lead continuous process improvement to ensure aggregate report processes and procedures are compliant

- Provide necessary data, metrics, key performance indicators to Sr. SABR management to ensure transparency into aggregate report activities

- Escalate issues associated with aggregate reports to Sr. SABR management in a timely manner, provide solutions to identified issues and implement agreed upon strategy.

- Manage vendors responsible for aggregate reports, including contracts, budgets and ongoing project oversight.

- Manage head count, budget and outsourcing to ensure proactive planning for upcoming aggregate reports.

*LI-RD2

Job Requirements:

QualificationsMinimum 8 years Pharmacovigilance experience, including management experience. Minimum 3 years experience with aggregate safety reports (DSURs, PBRERs, RMPs).
- Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology). Mentors others to develop these skills and provides oversight on deliverables representing this data.
- Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues. Fosters collaborative relationships and models expected team behavior.
- Oversees management and authoring of aggregate data reports. Oversees and mentors less experienced PV Scientist staff. Represents and speaks to these processes in cross-SABR and cross-functional forums.
- Applies clinical judgment to interpret case information, helps guide staff on clinical judgment and interpretation of case information.
- Subject Matter Expert in aggregate safety reports, including knowledge of applicable safety regulations. Includes knowledge of case processing, and safety database concepts. Demonstrates ability to mentor others and lead PV Scientists and SABR in decision making impacted by PV and drug development requirements.
- Strong organizational skills, including the ability to prioritize independently with minimal supervision. Ability to assess resource needs and adapt accordingly.
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems. EducationBachelor's Degree in biologic or natural science, or health case discipline Advanced degree (PhD, MPH, NP, PharmD, etc.) required. 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

Associate Director, Aggregate Reports - Drug Safety

col-narrow-left   

Job ID:

23091

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:

Associate Director, Aggregate Reports - Drug Safety

Job Description:

Associate Director Aggregate Reports will be in charge of establishing and leading a team of PV Scientists responsible for aggregate reports for investigational and post-marketing products (i.e., DSURs, PBRERs, RMPs).

The Associate Director Aggregate Reports is responsible for the following:

- Ensuring the necessary resources are available for planned and potentially ad hoc aggregate reports to ensure high quality, timely deliverables.

- Developing processes for aggregate reports that are compliant and meet relevant regulatory requirements, including aggregate report calendar / scheduling, writing, tracking, timeliness and quality.

- Hiring, training, mentoring and managing PV Scientist staff for aggregate report management

- Maintaining compliance with relevant regulatory requirements and implement corrective or preventive actions if non-compliance or potential non-compliance is identified

- Serving as Subject Matter Expert on aggregate report requirements and strategy within PV Scientist team, for SABR and cross-functionally

- Ensure aggregate report data outputs, database queries and data conventions are consistent with the needs of aggregate reports and meet relevant regulatory requirements

- Lead continuous process improvement to ensure aggregate report processes and procedures are compliant

- Provide necessary data, metrics, key performance indicators to Sr. SABR management to ensure transparency into aggregate report activities

- Escalate issues associated with aggregate reports to Sr. SABR management in a timely manner, provide solutions to identified issues and implement agreed upon strategy.

- Manage vendors responsible for aggregate reports, including contracts, budgets and ongoing project oversight.

- Manage head count, budget and outsourcing to ensure proactive planning for upcoming aggregate reports.

*LI-RD2

Job Requirements:

QualificationsMinimum 8 years Pharmacovigilance experience, including management experience. Minimum 3 years experience with aggregate safety reports (DSURs, PBRERs, RMPs).
- Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology). Mentors others to develop these skills and provides oversight on deliverables representing this data.
- Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues. Fosters collaborative relationships and models expected team behavior.
- Oversees management and authoring of aggregate data reports. Oversees and mentors less experienced PV Scientist staff. Represents and speaks to these processes in cross-SABR and cross-functional forums.
- Applies clinical judgment to interpret case information, helps guide staff on clinical judgment and interpretation of case information.
- Subject Matter Expert in aggregate safety reports, including knowledge of applicable safety regulations. Includes knowledge of case processing, and safety database concepts. Demonstrates ability to mentor others and lead PV Scientists and SABR in decision making impacted by PV and drug development requirements.
- Strong organizational skills, including the ability to prioritize independently with minimal supervision. Ability to assess resource needs and adapt accordingly.
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems. EducationBachelor's Degree in biologic or natural science, or health case discipline Advanced degree (PhD, MPH, NP, PharmD, etc.) required. 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
Copyright © 2016 NELEST.COM All rights reserved