GDS Alliance Lead

  • Company: Shire plc
  • Location: Massachusetts, United States
  • Posted: November 04, 2017
  • Reference ID: R0015544
% of Time
Job Function and Description
50%
Manage the development, review, negotiation, finalization, tracking and maintenance of global and regional pharmacovigilance agreements or pharmacovigilance provisions for Shire GDS partners, vendors and providers:
  • Develop new agreements using standard Shire templates as appropriate
  • Ensure PV provisions are current, feasible and aligned with regulations
  • Collaborate with internal GDS and cross-functional groups both within and external to Shire to ensure appropriate alignment with key stakeholders
  • Track and oversee PV relationship with assigned GDS partners, vendors and providers having PV-related responsibilities
  • Manage updates to the assigned PSMF Annexes
10%
Develop alliances with Shire's business partners in order to help ensure and protect Shire's global regulatory and legal position by establishing and maintaining comprehensive alliance management systems and documentation.
10%
Develop and maintain templates for PV agreements and pharmacovigilance provisions in accordance with Shire and industry standards.
10%
Develop, review and maintain standard operating procedures and guidance documents relevant to PVAs, PV language and related activities
5%
Establish and maintain tracking and systems for aggregate report information collection and report circulation for GDS business partners.
5%
Monitor Commercial Patient Program listings, reconciliation reporting and safety database partner reporting rules at regular intervals.
5%
Work with assigned partners as required to rectify any potential and actual deficiencies in quality and compliance standards related to PVAs and PV provisions; work with internal Shire staff and business partners to align on corrective and preventative actions.
5%
Support global expansion activities through participation in team meetings and providing GDS operations-related information and requirements.
Education and Experience Requirements
  • 5+ years' experience in the pharmaceutical or related industry with a solid understanding of pharmacovigilance regulations, safety data exchange, and risk management
  • Bachelor's degree or equivalent with advance degree preferred
  • Experience in Pharmacovigilance including knowledge of safety reporting for clinical trials and post-marketing authorizations to global regulatory authorities
  • Life science degree or healthcare professional preferred
  • Detailed knowledge of Pharmacovigilance Agreements and contract management
  • Practical experience with the interpretation and implementation of pharmacovigilance regulations
  • Knowledge of pharmacovigilance systems and user aspects of validation
  • Competence in business process analysis and process improvement
  • Competence in development and maintenance of standard operating procedures
  • PV audit and inspection experience desirable
Key Skills, Abilities, and Competencies
  • Excellent verbal and written communication skills
  • Strong interpersonal, networking and alliance management skills including expertise in negotiation and influencing others
  • Excellent project management, analytical and organizational skills
  • Demonstrated ability to ensure appropriate documentation for compliance with regulations
  • Proven ability to prioritize, schedule and meet deadlines in a changing environment
  • Excellent attention to detail
Complexity and Problem Solving
  • Ability to negotiate and resolve conflicts with vendors, partners and key stakeholders to ensure compliance for Shire and Shire's partners.
  • Ability to provide leadership and problem solving in a complex, fast-paced matrix environment.
  • Ability to understand different types of agreements and the safety information that may be related to each type of agreement.
Internal and External Contacts
  • Internal Contacts: GDS stakeholders including LOCs, Legal, Procurement, Regulatory Affairs, Regulatory Labeling, Quality, Commercial, Global Medical Affairs, Clinical Development, Technical Operations and Corporate Alliance Management
  • External Contacts: Shire business partners (e.g., license, marketing, co-marketing, development, co-development and promoters); vendors with services requiring PV-related provisions, Commercial Patient Program Providers (e.g., Specialty Pharmacies, Home Care Service Providers); and GDS Service Providers.


Share this Job