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/nontechnical 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 required 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 required
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 required
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 solid industry experience working 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
Serviceoriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment
Care to join us. Find out what life at Haleon is really like
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives generates curiosity to create unmatched understanding of each other and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect listening to different viewpoints supporting our communities and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you we encourage you to explore with our hiring team what the opportunities are.
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