Pharmacovigilance (PV) Alliance Manager

POSITION PURPOSE

Support the PV Alliance Management function and manage activities related to Pharmacovigilance Agreements and Safety Clauses with third parties with a high level of independence.

ACCOUNTABILITIES/RESPONSIBILITIES

• Expert in handling of authoring of various agreements

• Provides expertise and guidance to team members for monitoring compliance of pharmacovigilance or other safety agreements

• Extensively supports and resolves issues by liaising with various partners to ensure that appropriate partner compliance to Haleon is achieved

• Is a Subject Matter expert and understands, articulates and implements best practices related to PV Alliance Management

• Contributes to oversight and stabilisation of third party vendor model

• Proven experience in project management. Ability to lead project teams of various sizes and see them through to completion

• Independently plan, prepare and coordinate for audit/inspection programme and resolve the audit/ inspection findings for the team

• Lead Global Projects. Developing structured approach for better performance. Ensuring efficient project management procedures are implemented to enable monitoring of projects and accurate reporting of progress

• Conduct management monitoring to ensure set quality policies and procedures are being adhered to. Identify trends or training needs based on the management monitoring results.

• Identify process improvement areas in the team and develop plans to effectively improve the same

• Identifying and assessing future and current training needs

• Gain technical/non technical competencies outside of the team (when applicable)

• Accommodate additional technical/non-technical requests from various business units

• Expert in monitoring compliance by Haleon and partners with pharmacovigilance agreements by carrying out routine reconciliations and compliance checks and communicating standard information to partners as with appropriate guidance

• Expert in maintenance of information in the pharmacovigilance database, PVA database, PV Alliance Management website pages and shared areas including routine maintenance and documenting information as requested

• Expert in collection, evaluation, analysis and documentation of information received from Safety Regional Country Contacts.

• Expert in running standard listings from databases as

• Expert to administer document storage and archiving including team site per the approved processes

• Provides input/authors and maintains guidance documents and SOPs.

• Can independently interact with colleagues in Consumer Safety Science, Business Development, Operating Companies and external companies as necessary.

• Contributes to/leads projects relating to improvements in processes and systems e.g. PV agreements database independently

• Negotiates and revises PVAs as

• Ensures compliance with worldwide PV, materiovigilance and cosmetovigilance regulations, guidelines and industry practice

• Applies standardised contract guidelines in line with company polices and legal and regulatory constraints

• Conducts routine reviews of PVAs to ensure adherence with global requirements, Haleon business practices and the terms/status of the commercial agreement

• Trains internal and external stakeholders, as required, to ensure understanding of the terms of the PVAs

• Performs other duties as assigned

QUALIFICATIONS

Bachelor/Masters degree (scientific or medically related field is preferred) and with working experience in the pharmaceutical industry in clinical development, pharmacovigilance and information management or equivalent work experience.

COMPETENCIES AND SKILLS:

Technical

• Expert in PV/safety agreement authoring

• Expert knowledge of data collection and interpretation

• Expert PV/safety database search skills.

Behavioral

• Excellent oral and written communication skills

• Expert at critical thinking and solution oriented

• Excellent computer skills including Word, Excel, PowerPoint and Sharepoint.

• Ability to work independently with tight deadlines while under pressure; demonstrates planning and organizational skills

• Results driven with a sense of urgency that ensures timelines within personal control are met

• Good judgement, common sense and pragmatism

• Interact with relevant stakeholders/teams independently, to communicate any configuration changes

• Functions as a team player

• Ability to work independently

• Able to build and maintain relationships outside of functional area

• Proactive problem identification

• Bridges personal, business and cultural differences to work effectively in team settings.

• Proficient in stakeholder management and customer focus

• Demonstrates learning agility in line with the evolving needs of business

• Develops self and others

• Seek process improvements at a global level

• Adapt to changing technology

• Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment