Ofertes d'ocupació a PrimeVigilance

• Nivell d'experiència---
• Tipus de contracteA temps complert
• PublicadaNova

Teletreball

Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Description

• Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader
• Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process
• Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management
• Contributes to achieving company´s goals and objectives
• Works under supervision of ICSR Operational Lead
• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Line Manages assigned ICSR staff
• Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency)
• Proposes process changes to ICSR Operational Lead
• Manages ICSR deviations with ICSR Operational Lead support
• Reviews trackers and timesheet data and ensures accuracy
• Is involved in ICSR processing and 2nd QC of cases
• Support other departments, as approved and instructed by ICSR Operational Lead
  
  

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• Strong previous experience of PV in ideally a CRO environment
• Previous experience in a Line Management position
• Excellent communication (written and verbal) skills
• Organization skills, including attention to details and multitasking
• Delegation skills
• Planning and time management
• Technical skills
• Team working
• English – fluent (spoken, written)
  
  

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language
  
  

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships
  
  

• Nivell d'experiència---
• Tipus de contracteA temps complert
• PublicadaNova

Company Description

PrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Description

The Specialist, Regulatory and PV Network is responsible for providing the strategy based on regulatory requirements and for completing regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies.

The Specialist will also act as Local Contact Person for the designated country.

Job Responsibilities

Role and Responsibilities

• Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
• Provide intelligence on requirements and contribute to the development of the strategy and set up activities (Project Management Plan, joint operating procedures, POAs and core documents). Support identification of issues and corrective actions.
• Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports.
• Ensure correct training assignment to and training compliance by the LCPs.
• Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.
• Provide Clients expertise and guidance at national level.
• Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.
• Prepare client’s invoices and review/ approve vendors’ project invoices.
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
• Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
• Track LCPs' key performance indicators and prepare monthly summary reports.
• Provide feedback on performance of vendors to aid their assessment.
• Communicate suggestions for changes to departmental/company processes/procedures.
  
  

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
• Previous experience within the pharmaceutical/CRO industry
• PV training and/or working experience and other educational or professional background as required locally
• Fluent in English, both written and verbal
• Candidatemust be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance.
• Good planning and organizational skills
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Good attention to detail
  
  

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language
  
  

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships
  
  

• Nivell d'experiència---
• Tipus de contracteA temps complert
• PublicadaNova

Company Description

We are PrimeVigilance (part of Ergomed Group, a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Description

At PrimeVigilance, PV Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability.

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them.

The PV Officer should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) and have demonstrated experience in case processing. The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.

Responsibilities include:

• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review.
• Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations)
• Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.)
• Mentoring and training of new and more junior employees within the department, including procedure optimization and development
  
  

• Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing
• Demonstrated case processing experience
• Time and issue management, delegation, organization and multitasking skills with good attention to detail
• Strong interpersonal and communication skills
• Advanced English skills, both verbal and written, at least C1
  
  

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language
  
  

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships