IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Coordinate and manage the preparation, review, negotiation and processing of pharmacovigilance agreements. Preparation of pharmacovigilance system master files. Act as EU QPPV for small/medium size clients with simple PV systems.
Manage the day-to-day safety agreement development process for large complex projects
Act as safety agreement expert and key interface for internal staff ensuring consistency in approach, metrics and format
Manage project requirements, identify issues and interact with customers to resolve issues.
Assist in the negotiation of safety agreement text using approved processes and templates
Participate in complex negotiations of safety agreements as required.
Resolve safety agreement disputes and / or escalate irreconcilable issues to management team
Perform quality control edits on all documents
Provide advice, support and guidance as needed and serve as a mentor to colleagues
Represent safety agreements team at customer meetings and on internal task forces as required
Assist in the training and mentoring of safety agreements team
Prepare and maintain PSMFs
Reviews PSMFs prepared by other specialists
Work closely with team members to ensure collaboration and efficient working practices
May assume the responsibilities of EU QPPV or deputy QPPV as outlined in Quintiles Work Instruction: CS_WI_LS0013 Lifecycle Safety-Qualified Persons for Pharmacovigilance (QPPV)
Perform all other duties as assigned
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In-depth knowledge of Lifecycle Safety service lines
Proven staff management skills.
Excellent project management and communication skills.
Strong leadership, motivational and influencing skills.
Ability to work on multiple projects and manage competing priorities effectively
Effective mentoring and developed coaching skills.
Strong judgment, independent thinking, decision-making and problem solving skills.
Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree or educational equivalent in health science or other directly related field and 6 years' clinical research experience in a Contract Research Organization or Pharmaceutical company combining 4 years of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc) and 2 years' project management experience or equivalent combination of education, training or experience
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Regular sitting for extended periods of time.
May require occasional travel.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.