Pharmacovigilance Manager

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.

What will be your key responsibilities:

  • Executes project tasks primarily specific to the unit, but also cross-functional, including without limitation Global ICSR processing, Global Literature monitoring, Signal Management and Benefit Risk Management activities, Medicinal Product Management ( XEVMPD), Local project management (Local literature monitoring management, Local ICSR management, LPPV/LSO management, Monthly reporting and compliance monitoring), Regulatory Intelligence, preparation and QC of pre-marketing and post-marketing aggregate reports (e.g. PSUR, DSUR, PBRER, PADER, etc.) Risk Management Plans (RMP), Study protocols (interventional and non-interventional studies), product documentation (SmPC, IB), Pharmacovigilance system master file (PSMF), performing the EU QPPV and deputy EU QPPV roles, Oversight over the assigned Pharmacovigilance system(s), Management of project related PV contracts (PV service agreements, Safety data exchange agreements), Pharmacovigilance system master file management, EU QPPV EudraVigilance related activities
  • Executes other project specific task as and if required
  • Assign PV unit team members (PV specialist, PV associates, PV assistant) with project tasks and approach other unit team leads for resource allocation as and if required
  • Act as escalation point for project team members (PV specialist, PV associates) for technical project issues, technical tasks and process issues or client complaints in relation to the project or the technical work performed;
  • Escalate technical project issues further to the concerned unit team leads
  • Involvement together with other team members in the scoping phase when and if required,
  • Support the PV Business Manager in proposal preparation as and if required
  • Improvement of processes within the assigned Unit, ensuring a smooth run of the project, tasks and processes; ability to capture all running projects, tasks and processes within the unit and their relations to other units within the PV department.
  • Oversee the work performed by the project team members (PV specialists, PV associates, PV assistants) and ensure a high standard and quality of delivered work


KEY RESPONSIBILITIES:
  • Act as the EU QPPV and/or deputy EU QPPV on assigned projects, as applicable (responsibilities defined in separate Job description)
  • 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
  • Organize 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
  • Adhere to company’s processes and systems

What experience should you have:

  • English and thorough command of both spoken and written Dutch
  • 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 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

What do you get in return:

Friendly work environment
Multinational team with 30 nationalities
Flexible working hours, working from home
Remote work is possible
Meal vouchers, Multisport card
Dog-Friendly office
Possibility of professional growth
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