Pv Alliance Management Specialist

2 weeks ago

London, Greater London, United Kingdom Amicus Therapeutics Full time

Job Brief:

PV Alliance Management Specialist (Interim)

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.
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Position Summary:


The PV Alliance Management Specialist acts as the primary PV operational point of contact between the Amicus Global Drug Safety organization and strategic, third-party business partners/ PV vendors.

The incumbent will support the Director of PV Alliance Management to ensure that delegated PV activities are appropriately performed to ensure regulatory reporting compliance and compliance against PVA/ SDEA obligations.


In addition to collating PV performance metrics from business partners, vendors and affiliates; the PV Alliance Management Specialist will support in due diligence, vendor qualification, and safety reporting training activities, as per relevant Amicus standards and procedures.

The incumbent may be required to coordinate local aggregate PV reporting, RMP and regulatory RFI responses for distributor territories.

This position reports to the Dir. Regional PV & Alliance Management and is key to supporting the success of corporate market expansion goals.

ROLES AND RESPONSIBILITIES

The PV Alliance Management Specialist is responsible for:

  • Supporting global market expansion corporate objectives and Distributor Markets cross-functional team
  • Supports the Director Regional PV and Alliance management with vendor/partner qualification process and due diligence activities for new license partners/vendors.
  • Supports PV Alliance Management operations: tracking of PVA/ SDEA obligations and delivery of partner/ PV vendor mandatory training
  • Maintenance of business partner/ distributor lists
  • Acts as vendor/partner PV operational point of contact
  • Deliver safety and product complaint report training to external stakeholders and maintain records and associated training tracker
  • Support Pharmacovigilance agreements (PVA) authoring, negotiation and execution
  • Coordinates distributor markets local aggregate PV reports, RMP and other regulatory safety RFI commitments with Global Drug Safety & GRA colleagues
  • Supporting local safety contacts with planning and submission of local risk minimization implementation plans
  • Supports the PV Quality Systems Lead with partner/ vendor QE/ CAPA coordination and tracking
  • Supporting maintenance of PSMF annexes related to PV vendors, partners and organised data collection programs
  • Reviewing contract requests and assessing the need for safety reporting language inclusion in the contract or a standalone PVA/SDEA.
  • Support preparation of safety management plans for specific programs/ vendors
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Requirements:
Educational Requirements

  • Higher educational degree, preferable in any biomedical science field, pharmacy or nursing
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Professional Work Experience Requirements

  • Significant experience in the pharmaceutical industry with demonstrable experience in a PV functional role
  • Experience interacting with vendors/partners and performing oversight of pharmacovigilance activities under the responsibility of a third party
  • Working knowledge of format and requirements of industrystandard aggregate safety reports (PBRERs, DSURs), RMPs and PV agreements
  • Scientific medical writing experience desirable
  • Working knowledge of PV quality management system elements (SOPs, KPIs, CAPA etc.)
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Other skills/Attributes

  • Demonstrated alignment with Amicus Mission Focus Behaviors
  • Proven ability to organize workflow activities and prioritize operational issues
  • Able to take accountability for assigned deliverables and deliver timely results
  • Ability to work flexibly and demonstrate adaptability according to workload demands
  • Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external stakeholders
  • Ability to establish and maintain effective relationships within the organization and with third parties
  • IT proficient
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Travel

  • N/A
***- We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our "Three Pillars of DEI" are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement._

***- Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability,

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