CONTRACT SPECIALIST - PHARMACEUTICAL BACKGROUND, HIGH WYCOMBE
This role is working inside IR35
The responsibility of the Safety Service and Technical Contracts Administrator is to support in monitoring, reviewing, advising and uploading of contractual agreements that have pharmacovigilance implications.
1. Assist with the review and drafting where necessary of safety related service and technical agreements (jointly known as vendor agreements) (e.g. clinical trials, market research, patient support programs etc.) Including identification of agreements to be updated in the global database and agreements which require safety language insertion/update.
2.Assist with the review of agreements to determine if these are safety related and relevant to the Pharmacovigilance Master File (PSMF) and ensure these are marked in the global database accordingly. Review and create contract lists to be entered and updated in the PSMF on a quarterly basis.
3. Assist where necessary with negotiations and execution of safety related vendor agreements working closely with various internal and external business partners including but not limited to Regional PV Manager, GMO/OCMS Product Vigilance Management Team, PV Legal, Local Safety Officers, Legal and identification of Contract Owners.
4. Review and assist where necessary with creating templates or standard wordings for safety related vendor agreements) and the maintenance of such templates, including gathering internal stakeholder feedback and rolling out updates.
5. Review and assist where necessary with creation and maintenance of Standard Operating Procedures, FAQs and Guidance’s relating to the review of safety related vendor agreements.
6. Provide support before and during internal/external audits and inspections with respect to safety related vendor agreements.
7. Assist with contract database management including but not limited to uploading contracts, periodic review, renewals, terminations, update requests and revisions, representing the Global WW/ Regions in the International Contracts Database (ICD) Organization as Contract Administrator.
8. Provide general ad hoc advice and support (including training) and daily maintenance of email mailbox
DECISION-MAKING AND PROBLEM-SOLVING:
Review and confirm if safety related vendor agreements are accurately identified within the global contracts database. Confirm if an agreement is safety related and relevant to the PSMF by review and interaction with key stakeholders. Confirm if an agreement contains the sufficient level of safety wording by review and reference to procedural documents, policies, standards and regulations.
Research, advise and draft PV wording where necessary with respect to global and local regulatory implications.
Ability to work in a matrix organization forming close liaison with internal business partners including global safety organizations and local operating companies, regulatory, quality assurance etc., to support decision-making.
• Liaise with safety organizations, local operating companies, business functions and contract owners on safety related vendor agreements (daily).
• Liaise with internal/external business partners in negotiating safety related vendor agreements (3-4 days a week)
• Participate in periodic calls with safety groups, regional heads, local operating companies, business functions and contract owners (weekly)
• Liaise with internal business partners e.g. safety organizations, local operating companies, quality assurance, business functions and contract owners providing advice, support and training (weekly)
• Liaise with quality assurance group supporting internal/external audit or inspection requests (ad hoc)
EDUCATION & EXPERIENCE REQUIREMENTS:
Requirement: Degree, Legal Degree desirable
Technical Skills: Ability to understand and interpret contracts and agreements; Excellent database skills; Sufficient knowledge of Master Agreements related Procedures and Guidelines; Process Excellence skills & experience;
Interpersonal Skills: Team player; communication and presentation skills; proactive and self- reliant with a sense of responsibility, ownership and urgency coupled with an understanding of when to reach out to manager for supervision. Works well under pressure, good time management, Intellectual curiosity, results orientated, attention to detail, strategic thinking, collaboration & teaming, inner confidence, self-awareness and adaptability required. Demonstrates willingness to listen and learn and proven ability to make and respectfully explain proper decisions (even when this leads to tough business discussions) required.
Internal and Networking Skills: Ability to thrive in a global, cross functional environment; previous in-house experience preferred.
3 to 5 years
If this role is of interest, please contact Leizl Johnson for a confidential conversation