Job Details: Pharmacovigilance Associate


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
Pharmacovigilance Associate



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



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Type: Permanent
Payment: package
Category: Pharmaceutical

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