Director Of Pv Operations - Remote

Director of PV Operations - Remote
at ClinChoice (View all jobs)
United Kingdom
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds....
ClinChoice is searching for a Director of PV Operations to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
DUTIES & RESPONSIBILITIES
The Director of PV Operations will be responsible for delivering PV services to global clients. The PV team is responsible for supporting the diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer). The PV team works closely with the ClinChoice’s Global Delivery Centers in North America, Europe, and Asia to provide services to global clients.
Key Responsibilities:

• Ensure the PV team manages client projects as per the contractual agreements and delivers high quality services.
• Collaborate with the Global Head of PV and provide oversight and guidance to global team and delivery centers for projects which include but are not limited to:
• Signal detection & 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.
• Collaborate and at time initiate process improvement projects by working with global teams

• Provide progress of work-plans and the status of key project deliverables
• Identify innovative solutions to meet clients’ requirements and business objectives in partnership with global delivery teams and SMEs.
• Monitor, assess potential impact, and develop appropriate strategies for new or emerging regulations and propose new service offerings to management team
• Support the company with:
• Preparing bid-defense response for safety and clinical RFPs
• Support sales activities such as bid-defense meetings, new client interactions, capabilities presentation, etc. for safety and clinical projects.
• Maintain strong relationship with existing clients and have thorough understanding of our services
• Lead/participate in client interactions and governance meetings
• Advise on any new technology development and collaborate with internal team/external consultants to support design and implementation of new technology.

Qualification / Skills / Experience

• Physician or PharmD or PhD in life-sciences
• The successful candidate will have 10-12 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is must) and a working knowledge of key pharmacovigilance regulations and methodologies.
• Experience of 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 acknowledgement that we received it. If you have the requirements we need, you will be invited for 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.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice 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.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
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