Director - Pharmacovigilance

Location : United States – Homebased

Schedule : Permanent- FTE

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance with a quality-focused collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Director Pharmacovigilance on a permanent basis while working on projects from our varied client base ranging from small to big pharmaceutical biotechnology medical device and consumer health companies.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

• Serve as Subject Matter Expert (SME) for pharmacovigilance (PV) activities to support on and offshore teams including but not limited to ICSR signal management and risk strategy discussions.

• Ensure appropriate PV SOP and processes conforming with Global Regulatory requirements.

• Develop PV training materials to support new and existing projects.

• Participates in and contributes to the continuous process improvement efforts and standardization of pharmacovigilance processes and methods

• Participates in product team client and investigator meetings as applicable

• Cultivate and lead the relationship with new and existing client base within the Life Sciences Pharmaceutical Medical Devices and Biotech industry sectors for pharmacovigilance.

• Work with PV clients and collaborate on strategic issues to advance long-term partnership.

• Develops and participates in the development of safety strategies for company products in all stages of drug and product development.

• Work and collaborate closely with client safety experts in creating executing managing and monitoring safety projects assigned.

• Manage communication between clients and delivery teams ensuring timely and accurate alignment between stakeholders.

• Review safety documents and ensure compliance to regulatory and business requirements.

• Liaise with various safety teams in creating building and managing safety deliverables.

• Develop establish and promote PV functions services and solutions to clients and all business stakeholders.

• Monitors safety projects and deliverables to ensure all project KPIs are met as per contract agreement.

• Prepare both technical and project-related reports to track project status and progress. Provide timely updates to respective stakeholders.

• Support business development through various engagements by providing medical safety expertise in activities including but not limited to project proposals request for information etc.

• Conduct trainings on various safety activities and topics as assigned.

• Work closely with other departments in providing holistic safety solutions for clients.

• Manage safety projects as assigned.

• Understand the current bench-strength of the teams and work in partnership with HR and Talent Associates to address any development gaps in a timely manner.

• Work with global customer base and development team to establish development priorities.

• Promote advocate and disseminate PV programs services and solutions to all potential global business partners.

Education and Experience:

• Master’s Degree in life-sciences or related field and minimum 8 to 10 years of experience within clinical research organization or Pharma R&D services

• Five years of experience within the pharmaceutical industry with proven track record of building relationships with top pharma and/or medical devices clients.

Our Benefits:

• Excellent work-life balance

• Dedicated Line Manager

• Monthly meetings with line manager

• Full performance and development process with end of year reviews

• Team events and end of year party

• Career opportunities within in ClinChoice locally and globally

• Employee satisfaction survey - your feedback is important for continuous improvement.

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 4000 professionals in more than 20 countries across the Americas Europe and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

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 to 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.

Key words: Pharmacovigilance ICSR SOP PV Medical Device Biotech

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