Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Pharmacovigilance Manager

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9831
Closing Date: 19 Jul 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

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

Requirements:

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 ldunne@thornshaw.com 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

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

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.