Safety & Vigilance Support

Cooper Consumer Health: oltre un secolo di innovazione nel selfcare Nata più di cento anni fa come cooperativa di farmacisti, Cooper Consumer Health è oggi la più grande organizzazione indipendente di selfcare in Europa. offrendo soluzioni efficaci, sicure e convenienti per il benessere quotidiano.
La nostra missione è rendere la salute accessibile a tutti, aiutare le persone a prendersi cura della propria salute in modo autonomo, offrendo soluzioni efficaci e accessibili.
Grazie a un portfolio di marchi leader come Betadine, Duphalac, Armolipid, Audispray, Excilor e molti altri, oltre 80. 000 farmacisti consigliano ogni giorno i nostri prodotti.
Crediamo nella consapevolezza e nell’empowerment: vogliamo fornire alle persone le conoscenze e gli strumenti per prendere decisioni informate sulla propria salute.
We are looking for a Safety &Vigilance Support to join our Centre of Excellence in Monza with expertise in Cosmetics, Medical Devices and Food Supplements.
The role is an individual contributor.
He / She supports Safety &Vigilance Senior Manager to comply with the legislation belonging to vigilance/surveillance activities on the Company Medical Devices/ In Vitro Diagnostics, pre-market, and post-market.
He/she supports Safety &Vigilance Manager in keeping updated the surveillance/vigilance global data on Company Parapharmaceuticals, especially through management of Individual Case Safety Reports (ICS Rs) received worldwide, and in providing answers to product enquiries received from the markets (in collaboration with Quality Assurance; Medical and Local TeamKEY RESPONSIBILITIES Process Individual Case Safety Reports (ICS Rs) of the Company coming from clinical trials or from the markets via affiliates or distributors ( Medical Devices, In Vitro Diagnostic Devices, Food Supplements, Cosmetics, General sales).
Checking data for consistency and accuracy triggering follow-up requests to local teams if needed.
Ensure recording data in the Global Safety Database (triage/acceptance, Data Entry, Quality Check, Submission) Performing ICS Rs reconciliations with relevant stakeholders.
Supporting in writing or reviewing Standard Operating Procedures of the PMS System, where appropriate.
Ensuring Vigilance compliance KP Is are met.
Supporting in screening of scientific literature when needed and appropriate.
Supporting the Vigilance and Safety team in general activities and/or drafting vigilance documents.
Interacting with concerned internal departments, affiliates, and providers.
Join cross functional teams where appropriate.
QUALIFICATIONS Bachelor’s Degree in Scientific Disciplines ( Pharmacy, CTF, or similar) Knowledge and/or experience in Pharmacovigilance requirements/obligations are required (1-2 anni) Previous knowledge of Pharmacovigilance databases is welcomed.
Proficiency in speaking, comprehending, reading, writing English is required.
Able to work in team and problem-solving skills.
Good knowledge of Microsoft office ToolsEXPERIENCE Minimum 2 years in a similar role in Pharmaceutical, Chemical, Parapharmaceutical or personal care companies.
L Professional, often with limited relevant experience or working towards advanced education or license.
Problems may require complex analytical or problem-solving techniques to define and identify cause.
Requires evaluation, interpretation, and judgment to select the right course of action which may or may not be defined.
Interprets or explains data or information to deliver messages to audiences not knowledgeable about the subject matter.
Contributes to the achievement of functional goals through personal effort and may affect related activities in other functions (short-term impact. ) Accountable for planning the details of own work assignments.
PLACE OF WORK: Via Valosa di Sopra n. 9 – Monza (MB) La ricerca è rivolta a persone di entrambi i sessi (D.
Lgs. n. 198/2006) e nel rispetto di quanto disposto dall’art. 10 del D.
Lgs. n. 276/2003. “ Ai sensi degli Artt. 13 e 23 del Decreto Legislativo 196/2003 si richiede espresso consenso al trattamento dei dati personali.