Pre-market Pharmacovigilance Specialist

**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 30 countries with more than 6,000 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: Discover more here

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, chemical manufacturing and controls, 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) and Toronto (Canada).

Who we are looking for

Main Responsibilities

Participate to the Departmental meetings and cross-functional teams/study Specific teams

Compile and review of documents pertinent to clinical trials with regards to PV topics/involvement (e.g. study protocols, patient information sheets, request for proposal, clinical study reports, AE coding listings), including set-up of electronic SAE (eSAE) reporting and PV sections of investigator's brochures (IBs)

Set up of systems/tools suitable for PV management within a specific clinical trial (e.g. study configuration in the safety database, (e)SAE form creation, web portals, etc)

Attendance and presentation at investigators meetings, if applicable and review of investigators training materials

Monitor PV operations activities of CROs involved in clinical trials

Evaluate product quality complaints from clinical trials

Draft and update PV Agreements with monitoring CRO

Manage of clinical trials and Compassionate use/expanded access programs (where applicable)

Maintain compliance to relevant regulations, policies and procedures

Fill in registers used for cases compliance analysis and PSMF update

Support the line manager in developing and maintaining global SOPs/ WIs concerning clinical trials, according to the assigned task

Implement PV training programs in connection with the assigned tasks

Perform SAE/Adverse events of Special Interest (AESIs) reconciliation activities

Directly handle/oversight Individual Case Safety Reports (ICSRs)/pregnancy cases from clinical trials from receipt to submission (interaction with monitoring Contract Research Organizations - CROs)

Support the Global Pharmacovigilance Operations Third Parties Specialist and the Case medical review physician for activities performed by Pharmacovigilance Service Providers (PVSPs)

Prepare PV documents for their management and archiving in the (e)TMF

Upload PV documents in the EDMS through the appropriate workflows

Monitor the EMA and other international websites or tools for the activities under direct responsibility and to distribute the relevant information to concerned stakeholders

Monitor specific tools for PV intelligence purposes

Handle ICSRs related to clinical trials as contingency plan

Open deviations related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation

Operate as backup according to Head of Pre-Market unit’s indications

Participate in audit and inspection activities

Experience Required

Minimum 1-3 years of experience in Pharmacovigilance within Pharmaceutical and/or Biotechnology industry

Experience in clinical trials safety preferred

Education

Master degree in science, medicine, biology, pharmacy or related fields

Additional specific courses in Pharmacovigilance are considered a plus

Languages

Fluent English

Technical Skills

Good communication and interpersonal skills, with ability to