Title : Pharmacovigilance Project Manager
Location : Remote role, EST hours
Duration : 06 Months (Possible Extension)
Pay rate : $60 - $73 / Hr
Top 3 skills :
- PV CRO management
- Audit and inspection readiness
- PV process improvement
6-7 months assignment
Experience :
Minimum 4 years pharmaceutical or health care related industry experiencerequired.
Minimum 3 years PV experience with 1 year experience working with CROs, vendors, and relationship management requiredGlobal experience with CROs, vendors and relationship management preferredEducation :
Bachelors required. Advanced degree in scientific / medical field preferred.Good cross cultural understanding and experienceExperience in people management and well developed skills in teambuilding, motivating and developing people.Demonstrated skills in negotiation and consensus decision makingCritical thinking and analytical skills and ability to make key decisionsDemonstrated effectiveness in external partner relationship managementUnderstanding of medical / scientific terminologyGood knowledge of PV regulations for the global pre-and post-market, i.e. FDA, EMA, ICH GVPExperience with safety databases, including MedDRA and WHO DrugExcellent written / oral communication skillsAccuracy and attention to detailFlexible mindsetTeam worker with collaborative approachAbility to prioritize under pressureWell developed organizational skillsObjectives :
Serve as a primary liaison and point of contact for vendor operations and vendor oversight, including vendors performing case management, case intake (i.e., Call Centers), scientific literature review, etc.Oversee operations performed by the PV BPO vendor including contract compliance, quality and timeliness of deliverables.Serve as the primary liaison and point of contact for vendor operations including the PV BPO vendor and / or vendors performing case management, case intake, literature review; call centersProvide Subject Matter expertise (SME) during audits and inspections in the areas of case processing / case management activities, literature monitoring, legal case processing, vendor oversight, etc.Accountabilities :
Provide leadership and oversight on case management for the Global PV Operations Team to ensure adverse event information is processed accordingto company timelines and quality standards
Oversee regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to global Health Authorities, alliance partners, local operating companies (LOCs) including SUSAR and SAE communication to ECs and investigators as applicableIn partnership with the Global Standards and Compliance team, direct and manage communication with alliance partners, LOCs and CROs regarding the evaluation and processing of ICSRsIn partnership with the Global Standards and Compliance team, lead and direct the review and approval of alliance partner safety data exchange agreements for the inclusion of appropriate safety reporting requirementsEnsure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, metrics, and monitoring of performance and compliance, and training at a global levelOversee and direct reconciliation processes for case exchange with LOCs and alliance partnersDexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.
Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https : / / dexian.com / to learn more.
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
Salary : $60 - $73
