Pharmacovigilance Specialist - [DT-549]
Pubblicato il 23-01-2025 - Buscojobs in Ari
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), has been 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.
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, including close interactions with all local functions that may receive individual safety reports, including but not limited to Quality Complaints, Medical Affairs/Medical Information, and Sales Representatives.
Ensuring appropriate quality of all received reports through a deep analysis of safety reports and conducting 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 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 pharmacovigilance activities performed by contracted Pharmacovigilance Service Providers and Contract Research Organizations.
Monitoring of scientific literature when required.
Compliance: Working according to Teva guidelines to ensure compliance with European and Global Pharmacovigilance procedures, Working Instructions, policies, and the current standard Teva practice.
Participating in local gap assessments, when required, to ensure that EU WIs/Global SOPs include all local requirements.
Participating in the development of local addenda to describe local activities when required.
Assisting in 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 in the preparation during inspections and/or internal audits when required.
Providing support for other PV activities when requested.
Safety Review: Assisting in the management of any safety-related information relating to safety queries received from healthcare professionals, patients, and/or the 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: 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).
Proficiency 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, including smartworking days.
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.
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