JOB TITLE: SR. DIRECTOR PHARMACOVIGILANCE OPERATIONS, ITALY - P

Description.
Location.
Italy - Hybrid (2 days in office) Schedule.
Full-time, permanent   CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations.
The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients.
The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients.
Join our team and help us deliver clinical trials that will improve patients' lives.
Main Job Tasks and Responsibilities.
Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.
Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV Support Balancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.
Collaborates and at times initiates process improvement projects by working with global teams.
Provides progress of work plans and the status of key project deliverables.
Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.
Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.
Preparing bid-defense response for safety and clinical RFPs.
Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc.
for safety and clinical projects.
Maintains strong relationships with existing clients and has a thorough understanding of our services.
Leads/participates in client interactions and governance meetings.
Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology.
Education and Experience.
Physician or PharmD or PhD in life sciences.
The successful candidate will have years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.
Experience in people management.
Experience with CRO/BPO is preferred.
Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.
Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.
The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it.
If you have the requirements, you will be invited for a phone interview as the first step.
Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @ https://www.
alentsourcelifesciences.
om/jobs    please contact mailto.
[email protected] @cromsource.
om for more information.
Who will you be working for?   About CROMSOURCE       CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since , has been supporting our clients with outstanding clinical research and staffing solutions services.
The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos Our employees are the most valuable company asset.
We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents.
Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel.
The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.
The success of these core values is evidenced by our below-industry average turnover rates.
About TalentSource Life Sciences   TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions.
Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth.
For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.
CROMSOURCE is an equal opportunity employer.
All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status.
CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords.
Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions Skills.
Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, Pharmacovigilance Location.
Italy