Director, Pharmacovigilance (PV) Clinical Trials Operations

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 (PV) Clinical Trials Operations 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:

Position Summary:

We are seeking an experienced Director of Pharmacovigilance (PV) Clinical Trials Operations to lead our pharmacovigilance activities during clinical development. The ideal candidate will be responsible for overseeing the Safety Operations for Clinical Trial cases.  In addition they will workclosely with the Off -Shore team  responsible for Post Marketing safety. This role requires strong leadership skills, strategic thinking, and a deep understanding of clinical trial processes.

Key Responsibilities:

Leadership & Strategy:

• Develop and implement the pharmacovigilance strategy for clinical trials.


• Lead and mentor a team of PV professionals, fostering a culture of excellence and continuous improvement.


• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and quality assurance.

Safety Data Management:

• Oversee the collection, analysis, and reporting of adverse events and other safety-related data.


• Ensure timely and accurate submission of safety reports to regulatory authorities.


• Conduct risk assessments and benefit-risk evaluations for investigational products.

Regulatory Compliance:

• Ensure adherence to global regulatory requirements and industry standards related to pharmacovigilance.


• Prepare for and participate in regulatory inspections and audits.

Communication:

• Serve as the primary point of contact for safety-related inquiries from regulatory authorities, investigators, and stakeholders.


• Prepare and present safety data at clinical trial governance meetings and to senior management.

Process Improvement:

• Identify and implement process improvements to enhance the efficiency and effectiveness of PV activities.


• Stay current with industry trends and best practices in pharmacovigilance.

Skills:

• Strong understanding of global pharmacovigilance regulations and guidelines.


• Excellent analytical, problem-solving, and decision-making skills.


• Exceptional communication and interpersonal skills, with the ability to collaborate effectively across departments.


• Strong leadership capabilities and experience managing cross-functional teams.


• Ability to work in a fast-paced, dynamic environment.

Secondary Responsibilities:

• 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.

• 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 relationship with top pharma and/or medical devices clients.

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. 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, Clinical Trials

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