% 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
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
Key Skills, Abilities, and Competencies
- 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
Complexity and Problem Solving
- 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
Internal and External Contacts
- 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 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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.