Serm Associate Medical Director - Siena, Italia - GSK

GSK

Azienda verificata

Siena, Italia

3 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Site Name:
Italy - Siena, Warsaw

Posted Date:
Jun 7 2023

SERM Associate Medical Director

We're combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why.

We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

Job Purpose:

This role has the following important purpose: Provides medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.

Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate.

Makes recommendations for the further characterization, management, and communication of safety risks.

Key Responsibilities:

Scientific/Medical Knowledge PV Expertise: Responsible for signal detection and evaluation activities for assigned products. Drives production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician). Authors the SERM safety contribution to global regulatory submissions in partnership with the product physician
Crossfunctional Matrix team leadership: Supports and Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of crossfunctional teams in any SERM to detect and address product safety issues and ensures that riskreduction strategies are implemented appropriately in clinical study protocols and/or product labelling. Leads or participates in crossfunctional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency
Communications (verbal, written) and Influencing (internal PV Governance and External LTs): Presents complex issues to senior staff members at the GSK Senior Governance Committees. Demonstrates initiative and creativity in performing tasks and responsibilities. Proactively contributes ideas to improve existing operations.

_ Why you? _

Basic Qualifications & Skills:

Medical Doctor (physician) with additional relevant medical or scientific postgraduate qualifications.
Substantial experience in pharmacovigilance or drug development.
Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and postmarketing activities
Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
Experience working in large matrix organizations and fluent in English

Preferred Qualifications & Skills:

Communication skills and team player
Effective negotiation, influencing and persuasion to enable others in the matrix to understand own perspective

Job posting close date: 5th July

Ricordiamo che è necessario informare il proprio responsabile nel momento in cui si viene convocati per il colloquio di selezione_

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

GSK is an Equal Opportunity/Affirmative Action Employer.

All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

**Important notice to E