Sector: Life Sciences
Consultant: Harvey Havell
Salary: £61500 - £65900
Job Status: Permanent / Full Time
€70-75k + up to 20% bonus & company vehicle
Our client, a major global commercial pharmaceutical company are recruiting for an experienced Pharmacovigilance Manager for a permanent role for their office in Dublin Ireland.
- 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 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.
Key Activities and Responsibilities
- Management of the Local Safety Unit (personnel and activities)
- Ensures PV activities are properly resourced.
- 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.
If you feel like this is the right position for you, please click the apply button.
You will be working alongside the fastest growing recruitment company in the UK, who provide an unrivalled service to all of their clients and candidates across the United Kingdom. Seven currently offer the best contractor pay rates in the UK for Life Sciences, making us the best option for maximising your earning potential and career fulfilment. Seven Consultants are passionate about placing you in the best possible role, for the best possible rate, while providing a support platform, which is accessible around the clock.
Are you ready for the challenge? If so, we look forward to hearing from you.
What else can you expect from Seven?
– Specialist Consultant allocated to you with all the expertise you require.
– Excellent Payroll and Compliance System, ensuring that you are paid on time, every time.
– Access to Exclusive Rates, allowing you to gain earnings that no other agency can offer you.
– £250 Referral Bonus for every person you successfully refer to Seven.
If you are interested in this opportunity, please ask for Harvey in the Life Sciences team.