GPV Medical Safety Writer

3 settimane fa

Parma, Italia Chiesi Farmaceutici S.p.A. A tempo pieno

Team: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Temporary

Location: Parma, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas.

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

Who we are looking for

Purpose

Process owner (cross-functional) for developing a wide range of pharmacovigilance documents for the assigned global products within the specific therapeutic area, including but not limited to Periodic Safety Reports, Safety Strategy and Core Benefit-Risk Documents.

Main Responsibilities
  1. Aggregates (PBRERs, PADERs, DSURs, ACOs)
  2. To support the Coordinator in the global planning (for both molecules under development and those with a Marketing Authorisation);
  3. To be responsible for writing, consolidating, updating and distributing aggregates for global products with the cross-functional team;
  4. To be responsible for aggregates report submission to Health Authorities where applicable;
  5. To be responsible for compliance monitoring both for PSURs/PBRERs and DSURs submitted for global products/ molecules under development;
  6. To be QC Responsible for aggregate reports and global planning;
  7. To lead the process/project for cross-functional working teams;
  8. To manage related Health Authorities’ assessments (i.e., “requests for supplementary information -RSI);
  9. To support the Safety Physicians in writing the relevant sections of the documents for the Company products’ renewals in Addendum to the clinical overviews (ACOs) for global products and provide the necessary support in case of RSI during the renewal procedure;
  10. To support/act as QC responsible the Coordinator in the calculation of quality Aggregate KPIs;

Risk Management Materials

  1. To support TA Physicians in aligning risk management materials with the current approved documents including PBRER, ACO, PADER, RMP, presentations, and signal evaluations;

General

  1. To produce high-quality, accurate and fit-for-purpose documents with clear conclusions;
  2. To effectively and clearly communicate technical, medical, and scientific information in critical submission and internal PV documents to deliver high-quality reports within the specified timelines;
  3. To collaborate cross-functionally for continuous improvement of standards and best practices for medical writing;
  4. To upload pharmacovigilance documents for global products in the EDMS through the appropriate workflows;
  5. To monitor aggregates inbox and HA websites including CTIS for aggregate management purposes (e.g. EURD list, ASR RFI) and share the results with relevant stakeholders;
  6. To be the representative for MSW part in audits and inspections;
  7. To support QPO in compliance calculations related to PSURs/PBRERs and DSURs submission and to update the Regulatory Information Management System with PSURs/PBRERs submission in scope;
  8. To support QPO for SOPs and other controlled documents including Working Instruction and related training;
  9. To support QPO for service agreement preparation concerning aggregates.
Experience Required

Minimum 1 year of experience in pharmacovigilance (medical writing experience is preferred), with theoretical and/or practical knowledge of PSUR/PBRER, ACO, RMP and DSURs.

Education

Master’s degree in science, PhD or similar preferred.

LanguagesTechnical Skills

Capacity to work on situations or data requiring an in-depth evaluation of various factors:
- Data analysis;
- Previous medical writing experience;
- Procedures writing and training performance;
- Knowledge of domestic and international regulatory safety reporting requirements.

Soft Skills
  • Adaptability and flexibility
  • Conflict management
  • Quality orientation

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment. In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.

#J-18808-Ljbffr

  • Gpv Medical Safety Writer

    3 settimane fa

    Parma, Italia Chiesi Group A tempo pieno

    Who we are looking forPurposeProcess owner (cross-functional) for developing a wide range of pharmacovigilance documents for the assigned global products within the specific therapeutic area, including but not limited to Periodic Safety Reports, Safety Strategy and Core Benefit-Risk Documents.Main ResponsibilitiesAggregates (PBRERs, PADERs, DSURs,...

  • Medical Safety Writer

    4 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Job SummaryWe are seeking a highly skilled Medical Safety Writer to join our team at Chiesi Group. As a key member of our Pharmacovigilance team, you will be responsible for developing and maintaining high-quality pharmacovigilance documents for our global products.Key ResponsibilitiesDevelop and maintain pharmacovigilance documents, including Periodic...

  • GPV Medical Safety Writer

    4 settimane fa

    Parma, Italia Chiesi Group A tempo pieno

    Who we are looking for Purpose Process owner (cross-functional) for developing a wide range of pharmacovigilance documents for the assigned global products within the specific therapeutic area, including but not limited to Periodic Safety Reports, Safety Strategy and Core Benefit-Risk Documents. Main Responsibilities Aggregates...

  • Gpv Medical Safety Writer

    2 settimane fa

    Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    Team: RD, Pharmacovigilance Regulatory AffairsJob Type: Direct EmployeeContract Type: TemporaryLocation: Parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 employees (Chiesi Group).To achieve its mission of...

  • Gpv Medical Safety Writer

    2 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Date: 23 Oct 2024 Department: Global Pharmacovigilance Team: RD, Pharmacovigilance Regulatory Affairs Job Type: Direct Employee Contract Type: Temporary Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than...

  • GPV Medical Safety Writer

    3 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Date: 23 Oct 2024Department: Global PharmacovigilanceTeam: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: TemporaryLocation: Parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than...

  • Gpv Medical Safety Writer

    3 settimane fa

    Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    Team: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: TemporaryLocation: Parma, ITAbout us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of...

  • Gpv Medical Safety Writer

    3 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Date: 23 Oct 2024Department: Global PharmacovigilanceTeam: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: TemporaryLocation: Parma, ITAbout us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000...

  • GPV Medical Safety Writer

    6 giorni fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Date: 23 Oct 2024 Department: Global Pharmacovigilance Team: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Temporary Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with...

  • GPV Medical Safety Writer

    2 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Date: 23 Oct 2024Department: Global PharmacovigilanceTeam: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: TemporaryLocation: Parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than...

  • Gpv Medical Safety Writer

    3 giorni fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Date: 23 Oct 2024 Department: Global Pharmacovigilance Team: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Temporary Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with...

  • Pharmacovigilance Medical Writer

    3 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Job SummaryWe are seeking a highly skilled Pharmacovigilance Medical Writer to join our team at Chiesi Group. As a key member of our cross-functional team, you will be responsible for developing a wide range of pharmacovigilance documents for our global products.Main ResponsibilitiesAggregate (PBRERs, PADERs, DSURs, ACOs) development and submission to Health...

  • Medical Device Safety Specialist

    4 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Job SummaryWe are seeking a highly skilled Medical Device Safety Specialist to join our team at Chiesi Group. The successful candidate will be responsible for ensuring the safe use of medical devices and food supplements across the organization, providing expert advice, and maintaining compliance with regulatory requirements.Key ResponsibilitiesDesign, plan,...

  • Medical Device Safety Specialist

    4 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    About the RoleWe are seeking a highly skilled and experienced Pharmacovigilance Specialist to join our team at Chiesi Farmaceutici S.P.A. as a Medical Device and Food Supplement Vigilance Lead. In this role, you will be responsible for ensuring the safe use of medical devices and food supplements across the organization and providing expert advice on...

  • Medical Device Safety Specialist

    1 mese fa

    Parma, Emilia-Romagna, Italia Chiesi A tempo pieno

    About UsChiesi is a global pharmaceutical and healthcare group with over 85 years of experience, operating in 31 countries with more than 7,000 employees. Our mission is to improve people's quality of life by acting responsibly towards society and the environment.Job SummaryWe are seeking a highly skilled Medical Device Safety Specialist to join our team....

  • Medical Device Safety Specialist

    4 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Job SummaryWe are seeking a highly skilled Medical Device Safety Specialist to join our team at Chiesi Group. The successful candidate will be responsible for ensuring the safe use of medical devices and food supplements across the organization and providing expert advice.Key ResponsibilitiesDesign, plan, maintain, and update medical device, food supplement,...

  • Medical Safety Specialist

    2 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Job DescriptionWe are seeking a motivated Medical Safety Specialist to join our team at Chiesi Group. In this role, you will be responsible for developing a wide range of pharmacovigilance documents for our global products within specific therapeutic areas.Main ResponsibilitiesAggregate and manage pharmacovigilance documents, including Periodic Safety...

  • Medical Device Specialist

    1 mese fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Job SummaryWe are seeking a highly skilled Medical Device Specialist to join our team at Chiesi Group. As a key member of our Pharmacovigilance team, you will be responsible for ensuring the safe use of medical devices and food supplements across the organization.Main ResponsibilitiesDesign, plan, maintain, and update medical device and food supplement...

  • Medical Device, Combinations Specialist

    2 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Farmaceutici A tempo pieno

    Job SummaryWe are seeking a highly skilled Medical Device, Combinations Specialist to join our Global Pharmacovigilance team at Chiesi Farmaceutici. As a key member of our team, you will be responsible for setting up, maintaining, and evaluating the performance of the medical device vigilance and food supplement system, ensuring compliance with Health...

  • Medical Device, Combinations

    3 mesi fa

    Parma, Italia Chiesi Group A tempo pieno

    Who we are looking forPurpose•    To set up, maintain and evaluate the performance of the medical device vigilance and food supplement system, in compliance with the requirements of Health Authorities and Standards•    Promote the safe use of medical devices and food supplements across the organisation and provide expert advice•    To set up,...