• Snapboard
  • Activity
  • Reports
  • Campaign
Welcome ,

Chat with the recruiter

...Minimize

Hey I'm Online! Leave me a message.
Let me know if you have any questions.

Pharmacovigilance - Drug Safety Expert 2

In Massachusetts / United States

Save this job

Pharmacovigilance - Drug Safety Expert 2   

Click on the below icons to share this job to Linkedin, Twitter!
JOB TITLE:
Pharmacovigilance - Drug Safety Expert 2
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Rockland Massachusetts / United States

JOB DESCRIPTION :
role opened up due to leave.
2-3 years of exp is ideal (PV)
-training for 1st month
-ideal bill rate is $47
Role NOT expected to last past Jan 2022.
interview will be via Teams
-this job can be done fully remote, other than occasional mail check
-once C-19 passes, this role will eventually go on site
-Separate interviews w/ Team members.
IRT and RSG databases
-good communication
-good with computers
-PV/drug safety experience a plus

Description:

The Sr. Local Patient Safety Associate (LPSA) is directly accountable for performing all pharmacovigilance (PV) tasks allocated to the Local Patient Safety organization in the US. This includes oversight of vendor activities and performance of key activities specified by the Food and Drug Administration. Tasks have to be performed independently and requires specific scientific and pharmaceutical product expertise to ensure full compliance with all relevant global and local regulatory requirements and company standards.

1. Product safety surveillance
• Collection, assessment and interpretation of adverse event information to ensure global reporting obligations. Independently analyze and question data to determine appropriate course of action to meet regulations.
• Oversight of vendor handling local safety information including collection, registration and transmission to GPS as applicable in a timely manner
• Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner
• Ensuring global literature search strategy is in accordance with GPS procedures and local requirements
• Collaboration with medical information, quality assurance, complaint management and PDCSs to ensure safety reporting procedures are in place, safety relevant information is processed in a timely manner, and reconciliation is completed
• Keeping product knowledge up-to-date to ensure appropriate Individual Case Safety Report (ICSR) handling
• Performing required safety activities in the absence of the Manager; Local Patient Safety Office

2. Reporting to local Health Authorities and Ethics Committees
• Oversight and at least annual review of automatic post-marketing distribution rules to FDA
• If the Sr. LPSA is Health Care professional (HCP), supporting Patient Safety Specialist (PSS) on an ad hoc basis to determine the medical relevance of new information received for follow up reports in order to determine reportability to FDA
• If the Sr. LPSA is a HCP, supporting the PSS on an ad hoc basis to monitor appropriate database workflows to ensure timely submission of expedited ICSRs to FDA

3. Compliance related activities

• Using applicable tools (e.g. IRT) to ensure local compliance in terms of ICSR handling according to local regulations and company timelines
• Contributions to the Local PV file under the supervision of the Associate Director Compliance in close collaboration with cross-functions to support completeness, accuracy and that relevant information is updated in a timely manner

4. Tracking of clinical development and Patient Data Collection Systems (PDCS) activities in the assigned countries
• Supporting the Associate Director Compliance in keeping a complete overview of local / global clinical studies and PDCS (planned as well as ongoing) in the US
5. Training activities

Position Details

May 29, 2021
Health Care
S1620486060518777
Massachusetts / United States
Rockland
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Pharmacovigilance - Drug Safety Expert 2    Apply

Click on the below icons to share this job to Linkedin, Twitter!

role opened up due to leave.
2-3 years of exp is ideal (PV)
-training for 1st month
-ideal bill rate is $47
Role NOT expected to last past Jan 2022.
interview will be via Teams
-this job can be done fully remote, other than occasional mail check
-once C-19 passes, this role will eventually go on site
-Separate interviews w/ Team members.
IRT and RSG databases
-good communication
-good with computers
-PV/drug safety experience a plus

Description:

The Sr. Local Patient Safety Associate (LPSA) is directly accountable for performing all pharmacovigilance (PV) tasks allocated to the Local Patient Safety organization in the US. This includes oversight of vendor activities and performance of key activities specified by the Food and Drug Administration. Tasks have to be performed independently and requires specific scientific and pharmaceutical product expertise to ensure full compliance with all relevant global and local regulatory requirements and company standards.

1. Product safety surveillance
• Collection, assessment and interpretation of adverse event information to ensure global reporting obligations. Independently analyze and question data to determine appropriate course of action to meet regulations.
• Oversight of vendor handling local safety information including collection, registration and transmission to GPS as applicable in a timely manner
• Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner
• Ensuring global literature search strategy is in accordance with GPS procedures and local requirements
• Collaboration with medical information, quality assurance, complaint management and PDCSs to ensure safety reporting procedures are in place, safety relevant information is processed in a timely manner, and reconciliation is completed
• Keeping product knowledge up-to-date to ensure appropriate Individual Case Safety Report (ICSR) handling
• Performing required safety activities in the absence of the Manager; Local Patient Safety Office

2. Reporting to local Health Authorities and Ethics Committees
• Oversight and at least annual review of automatic post-marketing distribution rules to FDA
• If the Sr. LPSA is Health Care professional (HCP), supporting Patient Safety Specialist (PSS) on an ad hoc basis to determine the medical relevance of new information received for follow up reports in order to determine reportability to FDA
• If the Sr. LPSA is a HCP, supporting the PSS on an ad hoc basis to monitor appropriate database workflows to ensure timely submission of expedited ICSRs to FDA

3. Compliance related activities

• Using applicable tools (e.g. IRT) to ensure local compliance in terms of ICSR handling according to local regulations and company timelines
• Contributions to the Local PV file under the supervision of the Associate Director Compliance in close collaboration with cross-functions to support completeness, accuracy and that relevant information is updated in a timely manner

4. Tracking of clinical development and Patient Data Collection Systems (PDCS) activities in the assigned countries
• Supporting the Associate Director Compliance in keeping a complete overview of local / global clinical studies and PDCS (planned as well as ongoing) in the US
5. Training activities