Job Reference: J5632954
Updated On: 18/02/2020
Status: Now Interviewing
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Role OverviewWe are currently looking for a Product Surveillance Team Leader to join a leading Pharmaceutical and Medical Aesthetics company based in the Buckinghamshire area. As the Product Surveillance Team Leader you will be responsible for a team of Analysts and Specialists focused on the reporting of customer complaints and problems with a diverse range of Medical Device products.
You would lead a brand new team and ensure the complaints are reported accurately and that staff remain compliant to global and regional complaint handling regulations and internal procedures.
This is the perfect position for an experienced line manager with a customer complaints/service background to enter the Pharmaceutical and Medical Device industry.
Key Duties and ResponsibilitiesYour duties as the Product Surveillance Team Leader will be varied however the key duties and responsibilities are as follows:
1. Supervise the investigation and processing of complaints and Medical Device adverse events. You will ensure that you are your team remain compliant to global and regional regulations, including Medical Device Directives as well as internal processes.
2. Ensure the compliance of the complaints process through review and approval of reports to Regulatory bodies and Competent Authorities. You will be the main point of contact between your staff and external authorities and will Quality check all responses to the agencies.
3. You will work closely with other Team Leaders and your line manager to ensure the establishment and monitoring of performance matrics. you will monitor your teams work flow to ensure continued and consistent quantity and quality of reporting. Where necessary, you will carry out root cause analysis and raise CAPAs related to the complaints handling process.
4. You will effectively line manage your team from a technical and personal perspective. You will set time lines and work loads and be the team subject matter expert on the reporting process, training where appropriate. You will also develop the training plan with internal training team.
5. You will be involved in the hiring and development of your team including performance evaluations and employee disciplinary actions, as required.
Role RequirementsTo be successful in your application to this exciting opportunity as the Product Surveillance Team Leader we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline is preferred and would benefit the application in addition to experience within a customer facing / service role where you have managed customer complaints or enquires.
2. Proven industry experience of Adverse Event and vigilance reporting is ideal. Additional experience of Medical Device / MEDDEV guidelines to EU/EMEA regulations is preferred as well as knowledge of Good Documentation practise and quality and compliance procedures.
3. A working knowledge and practical experience with line management of a team is ideal for this position. Previous experience of monitoring staff is a must for this role.
Key Words: Product Surveillance | Product Vigilance | Customer Complaints | Customer Quires | Line Management | Supervisor | Mentor | Continuous Improvement | Quality Assurance | CAPA | Medical Devices | Medical Aesthetics | Training | MEDDEV | EEA | 93/42/EEC | GDP
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