Are you a Pharmacovigilance Associate? Are you interested in working in a centre of excellence based in Dublin ? If you have what it takes, send your CV to karen@jobcontax.com or call (091) 395625 for a confidential chat.
Pharmacovigilance (PV) Associate - Dublin
Employer
Our Client is a supplier of branded and generic pharmaceuticals in more than 150 countries across the world. The Group has 22 manufacturing facilities at 16 sites on 6 continents and approximately 8200 employees. In 2010 they set up a centre of excellence in pharmacovigilance, quality assurance and supply projects in Dublin.
Job Description
Provide support for the Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all products across Company Affiliate companies for which marketing authorizations are held.
A central point of contact for all medical writing projects, liaising with other Group departments as the need arises.
Undertake all research, creation, and editing of all documents to comply with safety and clinical updates according to the internal labelling documents for all company Products.
Develop a framework for setting internal and external deliverables against each medical writing project, to include project goals and objectives and measurement criteria and business outcomes for each project goal.
Conduct leadership, training and support of junior medical writing staff.
Delivery Objectives:
Manage delegated tasks from QPPV on a defined and ad hoc basis with the flexibility of mind-set and time resource this entails. This will include representation at meetings when required.
Review, advise and approve relevant local and global guidelines, policies, internal procedures and SOPs across company Affiliate companies
Support Risk Management Plans (RMPs) by serving as a coordinator for the acquisition and preparation of data for review from multiple sources
Collect and/or organize the data as part of Pharmacovigilance, RMP, product recalls and surveillance activities
Manage outsourced data collection, organization preparation with vendors as required
Collation of draft reports, progress reports required for updating Health Agencies of RMP activities
Assist in organizing or running searches of safety or regulatory databases
Provide support to related PV activities such as preparation of reports for surveillance support, collating reports for review of product quality data, support of health hazard evaluations, scientific presentations etc.
Participate in preparation of analysis and writing of ad-hoc and aggregate regulatory reports and labelling support documents as well as regulatory enquiries
Review cases to assess the need for follow up
Ensure Good Documentation Practice
Maintain awareness of Pharmacovigilance regulatory requirements and developments
Contribute to agreed PV Team compliance targets
Prepare clinical and non-clinical overviews
Serve in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs
Direct interaction with Regulatory authorities
Provide input to the SRM report and assist QPPV and Deputy QPPV to ensure timely distribution to all other related departments once the report is signed off by Group PV Head, the EU- QPPV, the deputy EU-QPPV, the Medical Advisor – PV, the Regulatory Affairs Manager/ Group Head- Regulatory, the Executive, Group Pharmaceutical Affairs, APTL,
Create and maintain contacts across all company Affiliate companies to enable them to gain maximum benefit for the business from Pharmacovigilance
Financial:
Project management of contractual and financial aspects of all medical writing projects and translations and the effective utilization of resources to keep processes cost effective.
Identification of project challenges to departmental line management and the financial impact thereof.
Medical Writing Accountabilities
Write clinical documents for submission to regulatory authorities, including but not limited to:
- briefing documents
- previous human experience summaries
- human pharmacology summaries
- interim and final clinical study reports
- common technical document (CTD) clinical overviews and summaries
- safety update/aggregate reports
- integrated summaries of safety and efficacy
Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with company SOPs and style guidelines.
Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
Safety
Work with line management to ensure that adequate SOPs exist for all safety related Pharmacovigilance activities to be carried out in line with Good PV practices and according to worldwide Pharmacovigilance and EU regulations/requirements, to include activities by independent contractors and other third-party vendors where necessary
Preparation and coordination of reviews of individual case safety reports as well as aggregate safety data
Manage safety related requests for systems or drug safety related information to ensure any requests are answered fully and promptly
Support Safety Physicians, such as case series review, data review, draft reports
Assess cases for seriousness and expectedness and identify SUSARs
Write safety reports for signal detection
Write Annual Safety Reports
Authoring safety summaries to support labeling changes
Authoring Executive Summaries on special safety topics
Participate in and general review meetings on safety data
Ensure appropriate review/input into post-authorisation safety study protocols and study reports at local and global level
To review AE listings to identify data issues and safety trends as required.
To provide PV support to data management in reconciliation
To follow up any queries / issues raised as a result of reconciliation
Training
Oversee training and mentoring other Pharmacovigilance officers and specialists
Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities
Maintain a high and up-to-date level of product and therapy area knowledge by attending conference, training courses, reading relevant medical and scientific literature
Outputs
Accurate data entry and case processing
Good documentation practice
Accurate assessment of expectedness
Identification of SARs and SUSARs
Monthly and Annual reporting to Competent Authorities, Ethics Committees, business partners, company Affiliate companies management, within timelines
Contribute to the design, medical and scientific accuracy and approval of promotional material and preparation of expert documents such as formulary applications to support the Company’s products
Update external product listings (e.g. MIMS, eMC) to ensure that the information available to customers about products is accurate and current
Contribute to the updating of the product and therapy area knowledge of the medico-marketing teams
Develop and maintain product information systems and standards in order to provide accurate product support
Knowledge and information sharing
Excellent attention to detail
Maintain rigorous adherence to written procedures, e.g. SOPs
Excellent written and oral communication
Knowledge
Pharmacovigilance practice and procedure
EU Competent Authorities and Regulations
Clinical Trial Methodology
Marketing Authorisation rules and regulations
Working knowledge and familiarity with clinical protocols, clinical study reports
Knowledge of principles of epidemiology and statistics
Good working knowledge of the relevant information sources: including printed publications, unpublished sources, databases, web sites, other departments, external bodies
Understanding of the principles of information storage and retrieval and skill in their application
Awareness of competitor products and activity
Requirements:
Biological/life Sciences Degree or equivalent
Documented experience in all aspects of pharmacovigilance
Experience working with Aris Global Database
Experience writing large safety reports e.g. ASRs, DSURs, PSURs is desirable
Experience working with MedDRA coding dictionary
Database entry and manipulation
Package:
Permanent position
Competitive Salary €30 -€35k
Annual Bonus
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720 Click to Connect with Karen on Linkedin
Similar Jobs
Amgen Jobs in Ireland
Jobs in Dublin
Are you a Pharmacovigilance Associate? Are you interested in working in a centre of excellence based in Dublin ? If you have what it takes, send your CV to karen@jobcontax.com or call (091) 395625 for a confidential chat.
Pharmacovigilance (PV) Associate - Dublin
Employer
Our Client is a supplier of branded and generic pharmaceuticals in more than 150 countries across the world. The Group has 22 manufacturing facilities at 16 sites on 6 continents and approximately 8200 employees. In 2010 they set up a centre of excellence in pharmacovigilance, quality assurance and supply projects in Dublin.
Job Description
Provide support for the Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all products across Company Affiliate companies for which marketing authorizations are held.
A central point of contact for all medical writing projects, liaising with other Group departments as the need arises.
Undertake all research, creation, and editing of all documents to comply with safety and clinical updates according to the internal labelling documents for all company Products.
Develop a framework for setting internal and external deliverables against each medical writing project, to include project goals and objectives and measurement criteria and business outcomes for each project goal.
Conduct leadership, training and support of junior medical writing staff.
Delivery Objectives:
Manage delegated tasks from QPPV on a defined and ad hoc basis with the flexibility of mind-set and time resource this entails. This will include representation at meetings when required.
Review, advise and approve relevant local and global guidelines, policies, internal procedures and SOPs across company Affiliate companies
Support Risk Management Plans (RMPs) by serving as a coordinator for the acquisition and preparation of data for review from multiple sources
Collect and/or organize the data as part of Pharmacovigilance, RMP, product recalls and surveillance activities
Manage outsourced data collection, organization preparation with vendors as required
Collation of draft reports, progress reports required for updating Health Agencies of RMP activities
Assist in organizing or running searches of safety or regulatory databases
Provide support to related PV activities such as preparation of reports for surveillance support, collating reports for review of product quality data, support of health hazard evaluations, scientific presentations etc.
Participate in preparation of analysis and writing of ad-hoc and aggregate regulatory reports and labelling support documents as well as regulatory enquiries
Review cases to assess the need for follow up
Ensure Good Documentation Practice
Maintain awareness of Pharmacovigilance regulatory requirements and developments
Contribute to agreed PV Team compliance targets
Prepare clinical and non-clinical overviews
Serve in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs
Direct interaction with Regulatory authorities
Provide input to the SRM report and assist QPPV and Deputy QPPV to ensure timely distribution to all other related departments once the report is signed off by Group PV Head, the EU- QPPV, the deputy EU-QPPV, the Medical Advisor – PV, the Regulatory Affairs Manager/ Group Head- Regulatory, the Executive, Group Pharmaceutical Affairs, APTL,
Create and maintain contacts across all company Affiliate companies to enable them to gain maximum benefit for the business from Pharmacovigilance
Financial:
Project management of contractual and financial aspects of all medical writing projects and translations and the effective utilization of resources to keep processes cost effective.
Identification of project challenges to departmental line management and the financial impact thereof.
Medical Writing Accountabilities
Write clinical documents for submission to regulatory authorities, including but not limited to:
- briefing documents
- previous human experience summaries
- human pharmacology summaries
- interim and final clinical study reports
- common technical document (CTD) clinical overviews and summaries
- safety update/aggregate reports
- integrated summaries of safety and efficacy
Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with company SOPs and style guidelines.
Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
Safety
Work with line management to ensure that adequate SOPs exist for all safety related Pharmacovigilance activities to be carried out in line with Good PV practices and according to worldwide Pharmacovigilance and EU regulations/requirements, to include activities by independent contractors and other third-party vendors where necessary
Preparation and coordination of reviews of individual case safety reports as well as aggregate safety data
Manage safety related requests for systems or drug safety related information to ensure any requests are answered fully and promptly
Support Safety Physicians, such as case series review, data review, draft reports
Assess cases for seriousness and expectedness and identify SUSARs
Write safety reports for signal detection
Write Annual Safety Reports
Authoring safety summaries to support labeling changes
Authoring Executive Summaries on special safety topics
Participate in and general review meetings on safety data
Ensure appropriate review/input into post-authorisation safety study protocols and study reports at local and global level
To review AE listings to identify data issues and safety trends as required.
To provide PV support to data management in reconciliation
To follow up any queries / issues raised as a result of reconciliation
Training
Oversee training and mentoring other Pharmacovigilance officers and specialists
Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities
Maintain a high and up-to-date level of product and therapy area knowledge by attending conference, training courses, reading relevant medical and scientific literature
Outputs
Accurate data entry and case processing
Good documentation practice
Accurate assessment of expectedness
Identification of SARs and SUSARs
Monthly and Annual reporting to Competent Authorities, Ethics Committees, business partners, company Affiliate companies management, within timelines
Contribute to the design, medical and scientific accuracy and approval of promotional material and preparation of expert documents such as formulary applications to support the Company’s products
Update external product listings (e.g. MIMS, eMC) to ensure that the information available to customers about products is accurate and current
Contribute to the updating of the product and therapy area knowledge of the medico-marketing teams
Develop and maintain product information systems and standards in order to provide accurate product support
Knowledge and information sharing
Excellent attention to detail
Maintain rigorous adherence to written procedures, e.g. SOPs
Excellent written and oral communication
Knowledge
Pharmacovigilance practice and procedure
EU Competent Authorities and Regulations
Clinical Trial Methodology
Marketing Authorisation rules and regulations
Working knowledge and familiarity with clinical protocols, clinical study reports
Knowledge of principles of epidemiology and statistics
Good working knowledge of the relevant information sources: including printed publications, unpublished sources, databases, web sites, other departments, external bodies
Understanding of the principles of information storage and retrieval and skill in their application
Awareness of competitor products and activity
Requirements:
Biological/life Sciences Degree or equivalent
Documented experience in all aspects of pharmacovigilance
Experience working with Aris Global Database
Experience writing large safety reports e.g. ASRs, DSURs, PSURs is desirable
Experience working with MedDRA coding dictionary
Database entry and manipulation
Package:
Permanent position
Competitive Salary €30 -€35k
Annual Bonus
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720 Click to Connect with Karen on Linkedin
Similar Jobs
Amgen Jobs in Ireland
Jobs in Dublin
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical