Director of ICSR- Pharmacovigilance (North America)
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Job Location:
Raleigh, WV - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
POSITION SUMMARY: Manages ICSR Management Unit for assigned staff and ensures all unit-relevant activities are delivered within agreed extent. Contributes to achieving companys goals and objectives. Performs project budget reviews and provides support to and management of the ICSR leads. Other responsibilities include independent analysis of workload productivity and utilization of resources and their appropriate redistribution to ensure performance of the highest quality as well as coordination with other departments for all activities related to the ICSR Management Unit. Strong experience in clinical SAE/SUSAR processing and staff management required.
Role and Responsibilities:
- Managing the assigned ICSR Management Unit effectively
- Ensuring adequate resources within the ICSR project teams to achieve the maximum level of productivity and utilisation
- Setting productivity targets for ongoing projects and reviewing proposed target updates as required
- Based on reports and analyses defining the appropriate reallocation of resources in ICSR Management Unit or working with the resourcing unit for reallocation to and from other units and departments
- Managing ICSR Leads/Line Managers to ensure all employees are adequately utilised and productive and reallocating employees to other ICSR Leads/teams as necessary
- Notifying the Resourcing department about the need for additional resources for assigned project teams if resources cannot be managed internally and officially opening the requests upon approval and budget confirmations
- Proposing the necessary changes within the project team processes to ICSR leadership
- Finding solutions and introducing best practices to increase productivity and utilization within the ICSR Management Unit
- Training and mentoring of ICSR Line Managers and senior staff.
- Preparing various analyses and reports
- Reviewing budgets and resource allocations for all new projects and new scope of work for existing projects and supporting Directors of Projects as applicable
- Supporting the Business/Commercial team during development of contracts and proposals as applicable
- Supporting the Operations and Project Analytics team as applicable
- Assisting HR in employee recruitment performance evaluation promotion retention and termination activities
- Reviewing and approving all Critical CAPAs from the ICSR Management Unit
- Reviewing and addressing any requests from Quality department regarding ICSR Management Unit
- Reviewing and updating PrimeVigilance operating procedures and guidelines as applicable
Qualifications :
Education qualifications and professional memberships: Life science graduate pharmacy nursing other healthcare related qualification or experience in pharmacovigilance - Intermediate.
EXPERIENCE: 7-9 years of work experience in pharmacovigilance within which 4-5 years of work experience in line manager role - Advanced.
SPECIAL SKILLS (Advanced):
- Excellent communication (written and verbal) skills
- Excellent organization skills including attention to details and multitasking
- Excellent management skills including delegation skills time and issue management
- Technical skills
- Team working
LANGUAGE SKILLS: English fluent (spoken written) - Full Professional;
PC SKILLS: Advanced literacy (MS Office) - Advanced:
Additional Information :
We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.
Our Offer
- Competitive salary
- Dynamic team of colleagues in a fast-growing company possibility for your quick career growth
- Multicultural environment English as a company language
- Strong emphasis on personal and professional growth
- Extensive and specialized trainings in pharmacovigilance internal trainings provided by skilled professionals but also prestigious trainings/seminars taking place abroad
- Friendly working environment with several social events per year
Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
About Company
Ergomeds fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed Clinical Research brand. ... View more
