Talent.com
Angelini Pharma
Clinical Safety Physician/ManagerAngelini Pharma • Roma, Italy
Clinical Safety Physician/Manager

Clinical Safety Physician/Manager

Angelini Pharma • Roma, Italy
7 giorni fa
Descrizione dell’offerta di lavoro

The Global Clinical Safety Physician is a the senior clinical safety expert and reports directly to the Global Patient Safety Head. The Global Patient Safety Manager is responsible for developing, managing, executing, and overseeing all aspects of the safety programmes for one (or more) pipeline asset(s) throughout the product(s') life cycle. GPSM plays a key role in coordinating technical functions within GPS to facilitate these responsibilities. The individual is accountable for collaborative contributions and partnerships with the integrated development or product team to deliver on these safety commitments, while also demonstrating GPS expertise and leadership.


I candidati sono invitati a leggere attentamente tutti gli elementi di questo annuncio. La preghiamo di inviare la sua candidatura tempestivamente.

Key Responsibilities Include:

  • Provide GPS Medical leadership and ensure proactive pharmacovigilance for assigned product(s)
  • Demonstrate advanced knowledge of safety concepts, per ICH, US, and international regulation/guidelines and GxP.
  • Synthesize complex data into actionable insights and translate technical issues into strategic discussions.
  • Build strong relationships with key stakeholders, representing and championing the role of safety in the organization.
  • Represent GPS Medical in inspections and audit activities.
  • Foster and support a collaborative working environment focused on inclusion, innovation, acceleration, and delivery.
  • Provide training, coaching, and mentor.
  • Experience and knowledge sharing to further advance the goals of the GPS group and wider enterprise.
  • Maintain compliance with corporate policies and relevant training curriculum.

Education:

  • Degree in Medicine; PhD (or other complementary degree) in scientific discipline is preferred.

Experience:

  • Minimum 5+ years’ experience in the pharmaceutical industry or clinical care setting.
  • Experience in neuroscience or rare disease area is a plus.
  • Knowledge of drug development process
  • Direct experience with global regulatory filing and interacting with major regulatory agencies e.g., FDA advisory Committees, Scientific Advice, etc.
  • Expertise in pharmacovigilance with deep knowledge of regulatory requirements and guidelines pertaining to drug safety.
  • Thorough knowledge and understanding of safety, including clinical safety, deliverables, standards, and processes at a global level; including pre and post launch experience.
  • Proven record of successful clinical safety delivery with demonstrated examples of strategic influence to portfolio/clinical studies/programs.
  • Demonstrated success in implementing projects and/or innovating.

Skills, Knowledge & Abilities

  • Strong analytical skills with the ability to critically interpret and apply scientific and clinical data for risk assessment and management.
  • Proficient understanding of epidemiology and statistics, with the ability to apply data-driven decision-making.
  • Fluent in English with highly effective written and verbal communication skills
  • Excellent interpersonal, organizational and negotiation skills
  • Receptive, engaging, and impactful contributor
  • Ability to thrive in a matrixed environment, effectively collaborating across cross-functional teams including Regulatory, Clinical Development, Medical Affairs, Commercial, and Quality.
  • Strong problem-solving and critical thinking abilities, with a demonstrated ability to manage complex issues and competing priorities.
  • Ability to work on multiple projects and function effectively in a fast-paced matrixed environment.
  • Commitment to business ethics and compliance, ensuring alignment with corporate values, industry regulations, and best practices.

Angelini Pharma is an equal Opportunity Employe

We believe that diversity is a huge value that contributes to individual and company success. xysqume We are committed to create a diverse and inclusive environment.


#J-18808-Ljbffr

Creare un avviso di lavoro per questa ricerca

Clinical Safety Physician/Manager • Roma, Italy

Offerte simili

CYS_Security Manager_CSC

LeonardoRome - Italy

Questa posizione è in Leonardo.Riassunto dell'opportunità da parte della.Il ruolo prevede supporto nella definizione di strategie di cybersecurity OT, valutazione della postura cyber, audit di comp... Mostra di più

 • In evidenza

Healthcare Project Manager

QuiCare Srlroma, lazio, Italy

QuiCare is a company leader in the development and management ofbinnovative projects, integrated solutions, and services to support chronic patients and their families.QuiCare works with leading bp... Mostra di più

 • In evidenza

Health & Safety Specialist | Aeroporto di Fiumicino

Lagardère GroupFiumicino, lazio, Italy

La posizione supporta la funzione HSE nella gestione delle attività operative correlate alla sicurezza sul lavoro nell’ambito del perimetro italiano, affinché sia garantito il rispetto delle normat... Mostra di più

 • In evidenza

Global Station Operations Lead (MRO)

Nayak Aircraft Servicesfiumicino, lazio, Italy

A leading aircraft maintenance company in Fiumicino is seeking a Deputy Station Manager to support operations and manage a team effectively.The role involves coordinating maintenance activities, en... Mostra di più

 • In evidenza

Physical Therapist $5,000 Sign-on Bonus!

Upstate Caring Partnersroma, lazio, Italy

Physical Therapist $5,000 Sign-on Bonus! /h3pPay $61,880.Month School Calendar Sign-on bonus Eligible! /pulliFull Time $5,000 /liliPart Time $2,500 (20 or more hours a week) /li /ulpAt Upstate Car... Mostra di più

 • In evidenza

Risk Manager

Renault Grouproma, lazio, Italy

Il Gruppo Renault è alla ricerca di una risorsa da inserire all’interno della bDirezione Compliance Internal Control /b di bMobilize Financial Services /b (società finanziaria del Gruppo Renault).... Mostra di più

 • In evidenza

Instrumentation Engineer - Hybrid, Mentoring & Growth

STI Corporate S.p.A.fiumicino, lazio, Italy

Milan seeks an engineer for the Instrumentation Automation Team to support the development of control systems for various sectors including Energy, Chemicals, and Oil Gas.Candidates should hold a... Mostra di più

 • In evidenza

Service Manager ambito Sicurezza

Clariterroma, lazio, Italy

Clariter Group /b è alla ricerca di un/a bService Manager /b per un importante Cliente a Roma.Opererà all'interno dell'area Sicurezza e avrà la responsabilità di garantire la qualità, la continuità... Mostra di più

 • In evidenza

Advisory & Audit Specialist - CPA/ACCA Ready

ITC WORLDWIDEfiumicino, lazio, Italy

A global professional services provider is seeking a Consultant in Fiumicino, Italy.This role involves understanding clients' needs, assessing risks, and preparing financial statements.Candidates m... Mostra di più

 • In evidenza

Health & Safety Expert

NTU International A/Sroma, lazio, Italy

NTU International A/S /b is leading a consortium for the implementation of the EIB funded project called: bJETP South Africa Transnet Decarbonisation Framework Loan /b and is searching for experts ... Mostra di più

 • In evidenza

SENIOR PLANNER & RISK MANAGER

ELT GroupRome - Italy

Questa posizione è in ELT Group.Il processo di selezione sarà interamente gestito ELT Group.ELT Group rappresenta un’eccellenza industriale nello sviluppo di tecnologie all’avanguardia per la Difes... Mostra di più

Safety Site Manager - Cantiere

Michael Page International Italia S.r.l.roma, lazio, Italy

Ottima opportunità di carriera /liliServizi Ingegneristici e progettazione /li /ulpbAzienda /b /ppIl nostro Cliente è una realtà ingegneristica italiana fondata nel 1978, che ad oggi conta oltre 40... Mostra di più

 • In evidenza

European AV Safety Operator — Training & Growth

TSMG Holdingroma, lazio, Italy

TSMG Holding is seeking Autonomous Vehicle Safety Operators to support testing, validation, and commercial robotaxi operations across Europe.No prior AV experience is required; comprehensive traini... Mostra di più

 • In evidenza

Senior Global Clinical Safety Leader

Angelini Pharmaroma, lazio, Italy

The strongGlobal Clinical Safety Physician /strong is a the senior clinical safety expert and reports directly to the Global Patient Safety Head.The Global Patient Safety Manager is responsible for... Mostra di più

 • In evidenza

MitraClip Clinical Specialist - Tuscany & North

Abbott Laboratoriesroma, lazio, Italy

Abbott Laboratories is seeking a Clinical Specialist in Rome to provide clinical and technical support for MitraClip therapy.This role involves building strong relationships with physicians and tea... Mostra di più

 • In evidenza

CYS_Security Manager_CSC

Leonardo Worldwide Corporationroma, lazio, Italy

CYS\_Security Manager\_CSCApplylocations: IT - Roma - Via Laurentina: IT - Milano - Nervianotime type: Full timeposted on: Posted Todayjob requisition id: R **Job Description:****Leonardo... Mostra di più

 • In evidenza

Dirigente Infermieristico per RSA - Provincia di viterbo

LavoropiùBomarzo - Italy

Questa posizione è in Lavoropiù.Il processo di selezione sarà interamente gestito Lavoropiù.Sanipiù Roma - Divisione Specialistica Sanità del Gruppo Lavoropiù - ricerca: .Dirigente Infermieristico... Mostra di più

 • In evidenza

Supervisor on Duty - Operations

AviapartnerFiumicino, lazio, Italy

Aviapartner isseeking motivated Supervisor on Duty - Area Operations -to join our Airside department in Fiumicino Airport.Part of the activities carried out by theSupervisor on Duty - Area Operatio... Mostra di più

 • In evidenza

Clinical Safety Physician/Manager

Angelini Pharmaroma, lazio, Italy

The strongGlobal Clinical Safety Physician /strong is a the senior clinical safety expert and reports directly to the Global Patient Safety Head.The Global Patient Safety Manager is responsible for... Mostra di più

 • In evidenza

Pharmacovigilance Specialist (salary €40-45K)

Shionogi Europeroma, lazio, Italy

Supporting Patient Safety and Pharmacovigilance Excellence /h3 pAt Shionogi, we are committed to improving global health through innovation, collaboration and scientific excellence.As our European ... Mostra di più