Safety Medical Advisor - International Pharma Milano

Safety Medical Advisor - International Pharma
Milano
Lombardia, Milano

On behalf of an European pharmaceutical group dedicated to the research, development, manufacturing and marketing of pharmaceuticals, with headquarters in Milan, and operations in the main European countries, we are currently hiring for a Safety Medical Advisor.

It's a client where I've had extremely good feedback from those who I have placed there before and things are only getting better!

JOB ROLE PURPOSE

The Safety Medical Advisor has the purpose to support the QPPV providing expert medical input to the assessment of the benefit/risk profile of corporate and local medicinal products, in development and on the market, as well as medical devices, cosmetics and food supplements.

MAIN TASKS & RESPONSIBILITIES

**The Safety Medical Advisor is responsible to**:

Support the QPPV for all the activities requiring a medical input;

Ensure the continuous monitoring of the benefit-risk assessment of medicinal products, medical devices, cosmetics and food supplement inside the Group;

Ensure the medical assessment of the safety data concerning all the products (corporate/local) and provide feedbacks on the products benefit-risk assessment and the identification/validation of potential safety signals;

Review the Individual Case Safety Reports (ICSRs) from medical perspective and products benefit-risk ratio;

ldentify and assess new safety signals for products in development or marketed (by means of medical assessment of individual case reports and/or periodic/ad hoc cumulative analysis of cases and analysis of published literature);

Ensure periodic medical review of the safety data to assess the benefit-risk ratio for all group products (corporate and local), and timely inform the QPPV of any new detected safety signal (Signal Detection analysis);

Participate to the preparation and review of the Development Safety Updated Reports (DSUR) for group sponsored clinical trials and of company sponsored Post-Authorization safety study reports prepared at HQ and Affiliate level;

Participate to the preparation and review of the Periodic Safety Updated Reports (PSUR) for Group marketed products at HQ and Affiliate level;

Participate to the preparation and review of the Risk Management Plans (RMP) for Group marketed products at HQ and Affiliate level;

Prepare the response documents to any request from the competent authorities for provision of additional information necessary to validate a new signal or confirm the benefit-risk ratio;

Ensure medical review of the reference safety information of Summary of Product Characteristic (SPC) and Company Core Data Sheet (CCDS) for group marketed products;

Prepare any document to support changes to the product labelling and the renewal of the Marketing Authorization, in collaboration with Regulatory and Medical departments;

Participate to the revision of the safety sections of protocols and clinical study reports of medicinal products, medical devices, cosmetics and food supplements in development within the Group;

Prepare and review the reference safety information of lnvestigator's Brochures (IB) and lnvestigational Medicinal Product Dossiers (IMPD) for medicinal products in development;

Participate to Drug Safety Committee (DSC) meeting as permanent member;

Participate to the preparation of the safety documents relevant to the benefit-risk assessment for medical devices, food supplements and cosmetics (e. g. , Trend Analysis, PSUR, PMS plan, cumulative safety reviews);

Provide support for the preparation of Clinical Evaluation Report (CER), Post-market Clinical Follow-up (PMCF) and PMCF studies;

Support in reviewing and updating safety sections of the Technical File for medical devices and dossier of non-pharmaceutical products;

Participate to Due Diligence for the evaluation of the safety related data/documents.

Position is based in Milan, smart working is possible 3 days per week.