Pharmacovigilance Officer, Team Leader (Line Management position)

PrimeVigilance; Roma; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

A global pharmacovigilance company in Rome is seeking a professional to manage safety reports and perform ICSR activities. Ideal candidates will have a life science degree and extensive ICSR experience, with strong communication and organizational skills. The company promotes diversity and offers a supportive and growth-oriented work environment.

Servizi

Training and career development opportunities

Strong emphasis on personal and professional growth

Friendly, supportive working environment

Opportunity to work with colleagues globally

Competenze

• Experience in pharmacovigilance required.
• Extensive ICSR experience desired.
• Ability to lead and mentor junior staff.

Mansioni

• Process Individual Case Safety Reports in compliance with regulations.
• Mentor and train new employees.
• Perform activities within the ICSR management unit.

Conoscenze

Excellent communication skills

Organization skills

Delegation skills

Planning and time management

Team working

Technical skills

Fluent English

Formazione

Life science degree or other healthcare related qualification

Descrizione del lavoro

Job Description

• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to) :
• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
• Performing ICSR follow up
• SAE / SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Reconciliation (clinical, partners)
• Personal data protection
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• MedDRA and WHO coding
• Database Outputs and Reports (including data for monthly reporting to clients)
• Workflow & resource management
• Mentoring and training of new and more junior employees within the department
• Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
• Supporting ICSR SMEs and contributing as one of ICSR SMEs
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe
• Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

Qualifications

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• Extensive ICSR experience including mentoring and leading reports
• 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)

Additional Information

Why PrimeVigilance?

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer :

• 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

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

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

We look forward to welcoming your application.