20 annunci per il ruolo di category specialist - lombardia (recruiting in corso)

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Pharmacovigilance Specialist (PVS )

Cosmo Pharmaceuticals
Lainate, Lombardia

Candidati adesso

Dettagli della posizione

Qualifiche

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Gestionale
Approvigionamento
Inglese
Terminologia medica

Descrizione completa della posizione

PURPOSE

Pharmacovigilance

LOCATION

Lainate (Milan)

Description

The Pharmacovigilance (PV) Specialist supports the Marketing Authorization Holder (MAH) entities of the Cosmo group ensuring their compliance with pharmacovigilance duties of the MAH.

The role acts as the key liaison point between Cosmo and the external, contracted pharmacovigilance (PV) service providers, managing pharmacovigilance responsibilities with distributors and commercial partners, and ensuring that all contractual, regulatory, and quality obligations are met. The position ensures that the MAH maintains ultimate accountability for patient safety and regulatory compliance, while delegating operational activities to an external, contracted PV service provider. The position ensures safety reporting obligations from and to territories where products are marketed outside the EU, in line with contractual agreements and MAH responsibilities.

The position reports to the Chief Scientific Officer, and liaise with the Global Head of Regulatory Affairs to align PV activities with regulatory tasks and duties of Cosmo's entities acting as MAHs.

KEY RESPONSIBILITIES

To ensure that the PV provider is notified of any changes to Market Authorizations held by Cosmo within the timeframes stipulated in the agreement and is aware of all new territory requirements and partners providing assistance as well to assess the requirements for local contact personnel in all territories and ensure all responsibilities are being made according to local legislation and suitable agreements are in place with vendors/partners to provide these services.
To ensure timely reporting of adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and periodic safety update reports (PSURs/PBRERs) in accordance with global regulatory requirements.
To develop and maintain PV SOPs in line with national and international requirements to cover all relevant PV responsibilities and ensure that these are shared with the QPPV.
To take responsibility for identifying all partners and vendors that are part of the PV system in order to ensure that due diligence and ongoing risks are monitored, and a suitable audit program is implemented.
To notify the QPPV of any issues arising from audits or inspections of Cosmo or any of their partners and to exchange relevant information including reports within the agreed timeframes and work with the PV provider and QPPV to assist in making decisions regarding potential signals and required actions.
To ensure that a procedure for product recall is in compliant with PV requirements and managed appropriately at Cosmo.
To provide data for the Cosmo PSMF as per the agreement and review and sign off it on a quarterly basis to ensure that the document is inspection ready at all times.
To be aware of requirements for updates to Risk Minimization Plans and of aggregate report requirements in all territories (i.e. PSURs, PBRERs and DSURs) and provide the required information to the PV provider.
To review compliance and Key Performance Indicators (KPIs) relating to pharmacovigilance and attend regular meetings with the PV provider and act as the key point of contact for PV queries at Cosmo for the PV provider, QPPV and Cosmo third parties.
To ensure audit readiness for both MAH and vendor-related PV activities and to support regulatory inspections by ensuring documentation and vendor oversight evidence are available.

QUALIFICATIONS, SKILLS AND ABILITIES

A BS degree in a biomedical or related life science.
Minimum 2-3 years' experience in pharmacovigilance, preferably with vendor management/ oversight and commercial partners exposure.
Excellent knowledge of EU GVP requirements and international PV regulations: good working knowledge of medical terminology is preferable.
Familiarity with pharmacovigilance system audits, inspections, and SDEAs.
Excellent English skills, written and spoken.
Excellent computer skills and experiences in the use of standard office programs (Word, Excel, Power Point, etc.)

OTHER REQUIREMENTS

Excellent oral and written communication, organizational and planning skills

APPLICATION

Email us with your CV, résumé or portfolio, and a cover letter explaining your motivation for applying. Please include the job title in your email subject line.

Please review our privacy notice for job applicants

Thanking you for your application and for sending your CV, pursuant to art. 13 and 14 of the General Data Protection Regulation (EU) 2016/679, we provide you with all the necessary information relating to the processing of your personal data. The processed data will be your personal data that you deem appropriate to include in your CV. We invite you not to provide in your CV Personal Data falling within the special category of Personal Data pursuant to art. 9 of EU Regulation no. 679/2016(such as, for example, racial or ethnic origin, political opinions, religious or philosophical beliefs, union membership, data relating to the person's health or sex life or sexual orientation). We therefore reserve the right to delete or make anonymous such data if it is entered anyway. We inform you that your personal data will be processed in order to carry out an objective assessment of your professional and personal requirements in relation to the possibility of hiring for an open position, or future contact in the event of the opening of new positions relating to your professional figure. In compliance with the Art. 6 of the Regulation, the Data Processing is necessary to take steps at the request of the data subject prior to entering into a contract. The personal data being processed are provided directly by you; during an interview, the Data Controller may collect further data, including particular data, collected directly from you or from other sources; personal data from public registers may also constitute processing, always for purposes connected with the correct management of the employment relationship; during the interview you will be given specific information. All the aforementioned data will be kept for a period of 1 year and only in the event of the establishment of the employment relationship will they be kept for the entire duration of the contract and in relation to the terms established by the relevant legal obligations. Without prejudice to communications made in compliance with legal obligations, all data collected and processed may be communicated to categories of subjects such as the personnel office, function or area managers, group companies and labor consultants. The rights enshrined in the Regulation (access, rectification, cancellation, restriction and opposition, portability, and the right to lodge a complaint with the Authority) may be exercised against the Data Controller by writing to the following e-mail address: [email protected] For more information, please view the complete privacy policy at the link: cosmohealthconfidence/privacy-policy

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