Kelly Scientific Resources for our Client, a multisite pharmaceutical company, is looking for a:
SENIOR MEDICAL DEVICES OFFICER
Area of Specialization: Medical Devices Vigilance.
-process medical complaint cases received by the Safety Surveillance Unit (hereinafter mentioned as SSU) regarding medical devices received from EU and Extra-EU country from any sources;
-creates and updates procedural documents as SOPs and WIs in compliance with the Local, European and International legislations and guidelines for Medical Devices;
-perform duplicate detection of identified medical complaints;
-review Medical Complaints information received for completeness and consistency, perform follow-up activities/Medical Complaints query management under the supervision of the Head of SSU or his Deputy;
-archive the Medical Device Vigilance (MDV) documentation and maintenance of the electronic archiving system;
-maintain and update the Medical Device Vigilance system for company and its affiliates, through retrieving and collecting on a timely basis information from all the relevant stakeholders (eg.: Regulatory Affairs, Clinical, Corporate Office, Communication, Sales, Affiliates, Third Parties, Distributors, etc.),
-oversight and monitor the MDV structure in order to assure that all the parties are constantly in compliance with the company SOPs and Policies.
The MDSO is also properly trained on Pharmacovigilance, Cosmetovigilance, Veterinary and Food Supplement Vigilance and can perform the above mentioned activities.
-Education: Medicine, Biology, Pharmacy, Chemical and Pharmaceutical technology, or other health care related professions or life sciences
-Minimum 5 years of experience in Medical Devices Vigilance within Pharmaceutical and/or Biotechnology industry is preferred.
-Medical Devices vigilance-related activities require an in depth knowledge of life sciences-related fields; thus, a high-level education in any health related subjects has to be expected
-IT Skills: good knowledge of the Office package. Added value the knowledge of safety databases
-Proficiency (written and verbal) in English if not native language. The knowledge of other languages is a plus.
-Influencing and leadership skills
Kelly Services S.p.A., iscritta in data 26/11/2004 nell'Albo Informatico delle Agenzie per il Lavoro, Sez. I., prot. n. 1098-SG. I candidati ambosessi (L. 903/77) sono invitati a leggere sul sito www.kellyservices.it l'informativa sulla Privacy (Regolamento UE 2016/679).
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.