• Job Description

  Req#: 47328
  job summary:
  The Global Regulatory Affairs and Drug Safety Alliance Management (GRADS AM) Specialist plays a key role in the GRADS AM Team, facilitating across functional teams, building relationships, and supporting the delivery of high-quality GRADS Agreements to ensure timely and accurate collection, safety review, processing and reporting of adverse event data in compliance with applicable global regulations and company standard operating procedures and guidelines. To this end, the GRADS AM Specialist guides and facilitates effective working relationships across the GRADS organization and cross-functionally with strategic departments within the company and its affiliates/subsidiaries to foster a smooth, accurate, and timely flow of activities related to PV Agreements (PVA)s as well as effective contractual relationships with GRADS service
  
  providers.
  
  The GRADS AM Specialist is versed in PVAs, Pharmacovigilance Exhibits (PVEs), and PV Service Provider Agreements and acts as a key contact person for internal and external customers, managing these alliances directly and working with the GRADS AM Team as well as in partnership with cross-functional staff. Working with the GRADS AM Manager, the Specialist may negotiate and maintain Agreements, including maintenance and reporting of KPIs/SLAs, and participate in vendor governance. The GRADS AM Specialist may assist in special projects assigned by the management of the GRADS AM department.
  
  
  location: Philadelphia, Pennsylvania
  job type: Contract
  salary: $52.00 - 56.66 per hour
  work hours: 9 to 5
  education: Bachelors
  
  responsibilities:
  The GRADS AM Specialists have a breadth of responsibilities which are prioritized within the GRADS AM Team, and may be assigned to:
  
  · Business Development & Opportunities
  
  · Global PV Vendor Services
  
  · Regional PV Vendor Services
  
  GRADS AM Specialist responsibilities may include PV alliance activities such as, but not limited to:
  
  · Serve as the liaison between Global Pharmacovigilance and cross functional organizations, acting as a Pharmacovigilance ambassador and domain expert as well as increasing awareness within Global Pharmacovigilance of cross-functional customer/stakeholder needs and dependencies, including PV Service providers.
  
  · Support implementation for new partnerships and maintenance/change
  
  · Support establishment and maintenance of PVAs/PVEs/SPOPs/WOs associated with new business initiatives and opportunities.
  
  · Interact with business process owners for additional information to address questions in establishing a PVA/ PVEs/SPOP/WO.
  
  · Coordinate the PVA/PVE review by the safety review team, summarize agreement comments, and participate in the negotiation of the agreement.
  
  · Contribute to resolving conflicts at team level or higher and facilitate decision making within the team. Escalate issues utilizing governance models and standard communication plans.
  
  · Coordinate implementation of PVEs for programs with the potential to generate safety information.
  
  · Collaborate with the cross-functional groups that have responsibility for activities that may generate adverse events or safety information such as (not limited to) Business Alliance/Development, Commercial, Medical Affairs.
  
  · Support collection of information required to update designated sections of the PSMF.
  
  · Organize and moderate meetings and author minutes/discussion summaries. Solicit items for and set agendas. Send draft minutes/summaries for comments to internal and external Service Providers and distribute final summaries to all participants and senior GRADS AM staff. Follow up with meeting participants on the resolution of action items from meetings.
  
  · Maintain and organize internal GRADS AM files (Agreements, supporting documents, meeting minutes).
  
  · Participate in maintaining GRADS AM company Portal and Mailbox.
  
  · Conduct ad hoc/special projects and analyses for GRADS AM management.
  
  GRADS AM Specialist Essential Functions
  
  · Adheres to company templates and GxP guidelines for documentation and communications
  
  · Ensures compliance with corporate and departmental policies, standard operating procedures, and timely completion of all assigned training
  
  · Other duties as required to support GRADS AM team
  
  · Participate in the development and maintenance of GRADS AM activity workflow processes,
  
  department policies, work instructions, standard operating procedures and training material when new and/or updated processes are introduced
  
  · May serve as an individual contributor or a project manager for functional projects or workflows.
  
  · May mentor other team members
  
  · Participation in Inspections and Audits as identified, as well as active role in maintaining a business-as-usual inspection-ready state of operating
  
  · Takes responsibility for personal development and continuous improvement including keeping up to date with pharmacovigilance practices, legislation and guidelines.
  
  · Work collaboratively with cross-functional teams to evaluate the performance, identify bottlenecks, minimize regulatory risks and recognize patterns of inefficiencies in current operational processes
  
  · Collaborate effectively with Quality Assurance, Legal, Procurement, and Project Management.
  
  
  qualifications:
  EDUCATION / REQUIREMENTS
  
  · BS/BA degree in health related or biological science related field
  
  · 3 plus years of pharmaceutical drug safety/pharmacovigilance operations experience
  
  · In depth knowledge of pharmacovigilance activities and processes, with a preference for experience in more than one PV functional area
  
  · Knowledge of current and emerging regulatory requirements and expectations including EMA GVP
  
  Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS.
  
  · Experience interacting with service providers or external business partners
  
  · Excellent teamwork and interpersonal skills are required, with ability to effectively collaborate with internal and external contacts, building strong sustainable relationships
  
  · Excellent oral and written communication skills, demonstrating professional maturity, confidence and competence
  
  · Ability to work effectively within a matrix organization to achieve desired outcomes
  
  · Track record of effective decision-making; makes good business decisions and analyses problems from multiple perspectives
  
  · Ability to work across cultures, including in a virtual environment
  
  · Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
  
  · Team Building, Motivating and Influencing Others without authority
  
  · Promoting Innovation and Process Improvement Maintaining activities
  
  · Negotiation skills Strong analytical skills Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills
  
  · Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
  
  
  skills: Pharmacovigilance, MS-WORD, MS-EXCEL, MS-Powerpoint, Drug Safety, ICH Regulations
  
  Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
  
  At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
  
  Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
  
  Applications accepted on ongoing basis until filled.
  
  
  
  
  
  

• About the company

  We provide outsourcing, staffing, consulting and workforce solutions within the areas of engineering, accounting and finance, healthcare, human resources, IT, legal, life sciences, manufacturing and logistics, office and administration and sales and marketing.

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