Arriello is a leading consultancy and solutions provider of risk management and compliance services to Pharmaceutical and Biotech companies.

We have teams working in premarket approval and post market Regulatory Affairs, Pharmacovigilance & Quality Audits,

We are a friendly, open company with people across 11 countries and we support clients across more than 120 countries

Pharmacovigilance Manager

Short job description

The position directly reports to the Team lead of the unit, engages in the technical activities performed within the primary Unit and works also cross-functional, providing assistance and support with technical activities to other units within the PV department. PV manager executes project related tasks and activities and is able to delegate activities to other team members within the unit (PV specialist, PV associate, PV assistant) as and if required, and ensures a high quality of the services provided.

Detailed Overview

  • Act as the EU QPPV and/or deputy EU QPPV on assigned projects, as applicable (responsibilities defined in separate Job description)
  • OR, lead Clinical Safety team members in supporting client engagements
  • Act as a local qualified/contact person for pharmacovigilance, as applicable (responsibilities defined in separate Job description)
  • Work on projects and tasks assigned by the unit team lead
  • Work on other activities as assigned by Associate Director of Technical Areas and/ or Director of Drug Safety according to PV Unit strategy
  • Manage a group of PV specialists, PV associates, PV assistants within the assigned projects
  • Organise meetings with project members as required;
  • Ensure the delivery of projects/tasks in accordance with client needs as per the contractual agreements and procedures in place;
  • Follow and achieve agreed personal KPIs and KPIs of the department
  • Act as a process owner for assigned PV processes assigned by the Team Lead
  • Provide training to project team members and other PV department employees on technical areas as needed
  • Participate on trainings, both internal and external as required
  • Improve teamwork collaboration by sharing best practices
  • Constantly seek for and take into consideration the client and internal feedback to improve the efficiency and quality of work within the assigned projects
  • Properly escalate to management all unresolved issues or identified improvements proposed for implementation;
  • Effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication, ensuring full compliance with the processes and project deliverables
  • Ensure that all CAPAs related to assigned projects and tasks are managed within the timelines;
  • Work cross-functionally and in collaboration with key stakeholders/customers, both internal (e.g., Commercial, Technical, Quality, Regulatory, Pharmacovigilance, etc.) and external (e.g., Competent Authorities, Clients, External Vendors, etc.)
  • Participate in business meetings, bid defences with current and potential clients, as and if required
  • Participate in audits and inspections, as and if required
  • Participate in company marketing and promotional activities, as and if required
  • Organise and file the document according to the company’s document management system
  • Use company’s databases, systems and any other IT tools applicable for the job in line with company procedures

Requirements 

  • English speaking and writing at proficient level
  • Bachelor’s degree or graduate in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences – advance degree (e.g. masters) preferable
  • Minimum of 4 years of experience working in a medical or safety department with demonstrable expert knowledge of medical terminology or experience working in a clinical safety, medical or safety department to sufficiently demonstrate the knowledge required. As assessed by the Director of Drug Safety
  • Detailed knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.)
  • Experience working with a safety database desirable
  • Knowledge of web-based communication tools for conferencing (Skype/Teams, WebEx, etc.)
  • Ability to delegate and oversee work of junior staff
  • Ability to provide training to junior staff
  • Excellent team player, able to build an effective team
  • Organizational and time-management skills, able to prioritize work and adhere to deadlines
  • Excellent communication skills
  • Maintains a positive, result-oriented work environment

Informace o pozici

Společnost
Arriello s.r.o.
Address
Olivova 2096/4, Praha – Nové Město
Required education: College
Required languages: English (Proficient)
Benefits: Bonuses, Sales commission, Cell phone, Notebook, Flexible start/end of working hours, Meal tickets / catering allowance, Holidays 5 weeks, Educational courses, training, Cafeteria, Refreshments on workplace, Contribution to sport / culture / leisure, Sick days, Occasional work from home, Corporate events, Work mostly from home, Foreign business trips, Dog-friendly office
Listed in: Chemical industry, Research and development, Pharmaceutical, Pharmacist, Pharmaceutical laboratory technician, Clinical studies assistant, Clinical Studies Manager, Clinical Studies Monitor, Medical Advisor
Employment form
Employment form: Full-time work
Contract duration
Contract duration: Permanent
Employment contract
Employment contract: employment contract
Employer type: Employer

Arriello s.r.o., Eoin Hanley
+420 604 629 924
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