Pharmacovigilance Specialist

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Teva, world leader with over 40.000 employees, in the field of equivalent medicines, with a differentiated business that also includes specialist medicines, over-the-counter drugs and the production and marketing of APIs (active pharmaceutical ingredients), is present in Italy for over 25 years with a commercial branch and manufacturing sites.
Our mission is simple: improve the wellbeing of our patients.
We care about them and about our colleagues, creating a respectful, diverse and inclusive working environment, committing ourselves to maintaining high standards of quality, compliance and safety, always respecting our values:

We all work for one company and we work together to achieve a common goal.

Main responsibilities and activities

In the Pharmacovigilance Department we are looking for a brilliant profile reporting to the Associate Director Pharmacovigilance with the following responsibilities and activities:

Main Responsibilities:

• Ensuring appropriate quality and accuracy of all case reports received from any source.
• Functional relationship with Global Drug Safety and Pharmacovigilance and local departments to ensure regulatory reporting compliance.

Main Activities:

• Processing all individual/periodic case reports received from any source to ensure regulatory reporting compliance. This shall include close interactions with all local functions with the potential to receive individual safety reports, including by not limited to Quality Complaints, Medical Affairs/ Medical Information, Sales Representatives.
• Ensuring appropriate quality of all received reports through a deep analysis of safety reports and conduction of follow-up activities.
• Ensuring accuracy and timely processing of safety information in compliance with Local and EU regulations and applicable SOPs/WIs and Teva policies.
• Performing case reconciliation with all the internal departments that could potentially receive safety information of Teva drugs and also with external companies/ Contractors, Third Party companies and service providers according to the responsibilities established in the signed PV agreements.
• Managing Pharmacovigilance systems.
• Monitoring of pharmacovigilance activities performed by contracted Pharmacovigilance Service Providers and Contract Research Organizations.
• Monitoring of scientific literature when required.

Compliance:

• Working according to Teva guidelines in order to ensure compliance with European and Global Pharmacovigilance procedures, Working Instructions, policies and the current standard Teva practice.
• Participating in local gap assessment, when required, in order to ensure that EU WIs/Global SOPs include all local requirement.
• Participating in the development of local addenda to describe local activities when required.
• Assisting on the preparation and execution of CAPA related to PV responsibilities when required in the event of deviations from SOPs/WIs/Case processing, agreements, regulatory requirements following internal audits and/or inspections.
• Participating in TrackWise system maintenance as requested (CCSI, CAPA, Agreements).
• Assisting on the preparation during inspections and/or internal audit when required.
• Providing support for other PV activities when requested.

Safety review:

• Assisting on management of any safety-related information relating to safety queries received from healthcare professionals, patients and/or Italian Competent Authority on local Teva products; this in conjunction with Global Pharmacovigilance, as appropriate.
• Referring promptly any local safety issues that arise to the Associate Director PV.

Requirements

Background:

• Good medical/scientific knowledge
• At least 2 years of experience in the role (case processing, reconciliation, SOP writing, literature)

Skills:

• Good analytical and problem-solving abilities
• Good knowledge of English and Italian languages
• Familiarity with national and European drug safety regulations
• Ability to work collaboratively in a team (including with cross-functional teams: regulatory affairs, QA and medical affairs)
• Good in industry-specific software and database systems
• Good organizational skills

What we offer?

We try to take care of our employees, offering them small and large benefits. By way of example:

• Ticket Restaurants for each working day, smartworking days included
• Working flexibility for Caregivers and parents
• Recognition Program
• Welfare Platform
• Health agreement with medical centers of excellence
• Flexible working environment (2 days home office per week)
• Highly inclusive and multicultural working environment
• Continuous learning and development programs (with full access to Linkedin Learning!)

Type of contract: long term contract

Location and working program

Assago (MI), from Monday to Friday.

Teva's commitment to equal opportunities

Teva is committed to equal opportunities in the world of work. Our global policy requires equal employment opportunities to be provided regardless of age, race, religion, health, identity, gender expression, protected categories or any other legally recognized status that is entitled to protection under applicable laws.