Pharmacovigilance Project Specialist

Department:              Pharmacovigilance

 

Job Holder:               

 

Reports to:                 COO and Head of Pharmacovigilance Department

 

Number of Direct Reports: 1 (Project Assistant) 

 

           

MAIN PURPOSE OF ROLE:
 

Work in a team that works across the unit and organisation to:

  • Be part of the Pharmacovigilance department  
  • Execute project related activities and provide support for junior staff
  • Support business development activities when required for the current and future clients by providing technical information over the phone or during face to face meetings
  • Work cross-functionally and in collaboration with key stakeholders/customers both internal (e.g., Commercial, Technical, Quality, Regulatory, etc.) and external (e.g., Competent Authorities, Clients, External Vendors, etc.)

 

KEY RESPONSIBILITIES:

Execute and have the overview of the Pharmacovigilance activities in the department, mainly projects that are involved the third parties’ vendors, which includes but not limited to:

  • Support Pharmacovigilance Department in  
    • Working the projects that involve the third parties’ vendors
    • Organize, file, track activities related to the vendor based projects
    • Participate in meeting related to the projects internally and externally
    • Provide support to other project managers in Pharmacovigilance department related to the on-going projects and tasks
  • Delegate administrative tasks to junior staff
  • As and when required work on aggregate reports
  • Manage assigned pharmacovigilance projects in line with client’s expectations
  • Participate in internal and external audits
  • Participate at internal and external trainings
  • As and when needed participate during vendor audits
  • Communication with clients, authorities and any third parties’ stakeholders
  • Organizing and filing the document according to the company’s document management system
  • Using company’s databases, systems and any other IT tools applicable for the job
  • Work with the project assistant to deliver necessary documents to clients, authorities, any other third party stakeholders
  • Deliver facilitating and enabling solutions to add new business opportunities for current or future clients
  • Lead delivery of required service levels from the respective Pharmacovigilance partners and take remedial actions as needed
  • Ensure high level delivery internally that adapts to changing requirements
  • Identify gaps and areas for improvement and lead remedial actions and initiatives
  • Participate at industry events and trainings when required
  • Participate during any related business activities, i.e. meetings with clients, trade shows, etc.
  • Adhere to company’s processes and systems
  • Liaising with Pharmacovigilance Department for the update of the information on licenses and exchange of important information

 

KEY ACCOUNTABILITIES:

  • Excellence in delivering projects to clients
  • Delivering solutions to issues in collaboration with partners and internal stakeholders
  • Precise alignment with Pharmacovigilance (and other) partners in respect of ongoing and required activities
  • Effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication.
  • Excellent cross-functional teamwork with Operations colleagues to ensure full compliance

 

PERFORMANCE STANDARDS:

  • High Pharmacovigilance compliance levels
  • No preventable Pharmacovigilance cause for customer complaints
  • Meeting the milestones and deadlines in accordance to quality and time


    Pharmacovigilance Project Specialist

 

Requirement

Essential

Desirable

 

Qualifications:

 

 

Bachelor’s degree in Pharmacy or Life Science

Post graduate qualification in a relevant scientific discipline

 

 

 

 

 

X

 

X

 

Experience & Competences

 

 

Significant Pharmacovigilance experience across EU and any other markets within the Pharmaceutical Industry

 

X

 

Previous line management and leadership role

 

X

 

Proven change management experience

 

X

 

Experience of working with external suppliers and partners

X

 

 

Relevant EU and/or other markets Pharmacovigilance training

 

X

 

Knowledge & Skills

 

 

Pharmacovigilance requirements across EU and/or other markets

 

X

 

Ability to work cross-culturally with external partners and agencies

X

 

 

Ability to work collaboratively and in a cross-functional environment

X

 

 

Customer-focused

X

 

 

Ability to recognise new business opportunities

X

 

 

Innovative solution finding

X

 

 

Strategy setting, planning and implementation

X

 

 

Influencing and negotiating

 

X

 

Excellent attention to detail

X

 

Personal Qualities

 

 

  • Motivating department to ensure a high level of performance
  • Positive can do, will do attitude. Wanting to progress the department forward, by doing the job to the best of your ability
  • Role model of desirable behaviours and ways of working
  • Working with integrity, believing truth matters and acting with positive motives at all times.
  • Calm and forward thinking in their approach
  • Sets ambitious goals and high standards
  • Strives for quality and eliminates mediocrity
  • Approaches work with a sense of urgency
  • Commits to action and implements promptly, does not postpone issues

X

 

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