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Job Details

Pharmacovigilance Manager

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9831
Closing Date: 16 Aug 18
Type: Full Time
Salary (£): Negotiable

Job Summary:

Our client, a global pharmaceutical company, are currently recruiting for a Pharmacovigilance Manager. This is a permanent position. 


Our client, a global pharmaceutical company, are currently recruiting for a Pharmacovigilance Manager. This is a permanent position. 

Pharmacovigilance Manager

  • Fulfils the role of Local Safety Responsible (LSR) for Ireland. 
  • Ensures that collection, reporting and handling of safety information associated with company products is performed according to company and local regulatory requirements.
  • Maintains oversight of safety risk management and all other pharmacovigilance (PV) activities and ensures PV compliance and inspection readiness across all affiliate functions.
  • Management of the Local Safety Unit (personnel and activities).

Key Activities and Responsibilities
•    Management of the Local Safety Unit (personnel and activities)
o    Ensures PV activities are properly resourced.
o    To lead, motivate and develop the PV team to achieve their objectives and provide high profile motivational leadership & direction to the PV team.
•    Oversight of Risk Management Plan Implementation;
•    Ensures that the management of safety queries, other significant safety issues and, if applicable, local/global crises is performed according to company and local regulatory authority requirements.
•    Acts as a point of contact for local Health Authorities and ensures communication of relevant safety information to external key stakeholders (as applicable)
•    Ensures appropriate safety reporting processes are in place at affiliate level for interventional and non-interventional clinical studies, Market Research and Patient Support Programs (MAPs), Pre-Approval and Post-Trial Access Programs and Compassionate Use in accordance with company policies and procedures, global and local regulatory requirements.
•    Ensure the implementation and maintenance of a PV Quality System in the affiliate in accordance with global company and local regulatory authority requirements.
•    Assumes responsibility for educating and training relevant personnel in the affiliate and promotes PV standards across the local affiliate.

Key skills and requirements

  • Healthcare professional (physician, pharmacist or nurse) preferred but a Life sciences graduate with significant experience in PV (especially operational PV) may be considered. A post graduate qualification is an advantage.
  • A minimum of 5 years PV experience, with at least 3 years of that PV experience within an affiliate/local country office setting of a biopharmaceutical company preferred.
  • Minimum of 2 years line management experience.
  • Good organisational skills with excellent attention to detail and the ability to think strategically.
  • Excellent knowledge of the EU PV legislation and experience of practically implementing the requirements.
  • Experience in and knowledge of other Medical related functions (e.g. Clinical Research, Medical Information and Regulatory Affairs etc.).
  • Experience working cross functionally with Medical, Market Access, Marketing and Sales colleagues at a local and also a regional/global level as applicable.

If you are interested in applying for this role please call Linda on +353 1 2784671 or email 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group.

Apply for this job: Pharmacovigilance Manager

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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