Pharmacovigilance Agreements Expert

Job title: Pharmacovigilance Agreements Expert 

Location: Hyderabad 

Main responsibilities:

• Within the CHC – Consumer Safety organization, under the direction of the Global Science CoE Lead, the Pharmacovigilance (PV) Agreements Expert will be responsible for management of PV Agreements for CHC products, manages PVA development- planning, execution, maintenance, life cycle management and termination (when applicable) of PVAs and associated deliverables and supports strategy setting, with input as necessary from line management, and supports inspection readiness in relation to PV Agreements. 
• Develop Pharmacovigilance Agreements (PVA) and support the PVA processes across the CHC organization in liaison with all the stakeholders as follows:  
  • Provide guidance to and/or may lead/co-lead projects; develops and manages plans to achieve objectives that relates to business partnerships  
  • Consolidate partnerships to promote awareness and understanding of PV Licensing processes and deliverables to ensure effective collaboration with key internal/external interfaces (Regulatory, Business Development, Legal, Contractual Partner, etc).  
  • Take informal leadership role during team meetings to facilitate agreements and move toward goals; take responsibility for a portion of the team's deliverables; may lead operational team(s).   
  • Support the development of PV Licensing strategies.  
  • Actively participate in periodic operational staff meetings to share best practice and foster continuous improvement.  
  • In collaboration with the CHC organization functional lines and subject matter experts, drive and implement relevant planning, execution, and governance strategies associated with PV Licensing arrangements enacted in the organization.  
  • Support the alignment with CHC Business Development goals as it relates to the overall delivery of quality PV Licensing agreement deliverables.  
  • Build strong relationships with relevant customers and stakeholders to drive collaborative partnership with PV Licensing team across the organization when impacting CHC products. 

Technical Tasks:

• Support to set-up the PVA life cycle (to prepare amendment, termination letter, new PVA)
• PSMF PVA activities support
• PSR partner tracker maintenance and support (introduction of PSR/DSUR/PBRER for the partner part)
• Maintain and provide monthly contact’s partner listing to SMEs
• Support PVA manager to revise QD to simplify the process 
• Management of the roll out of the PVA
• Management of the PVA global repository / sharepoint (access, organization)

About you

Experience:

Experience in consumer healthcare, pharmaceuticals, or related industries, ideally 5+ years in pharmacovigilance or drug safety. Previous experience in driving operational excellence, tracking of KPIs and continuous improvement of processes and performance.

• Minimum of 5 years of experience in ICH-GxP-related operations, of which 2+ years’ experience in PVA process management, is mandatory.
• Knowledge of international regulations/Guidelines/Good Practices pertaining to the ICH-GxP
• Good depth understanding of PVA systems
• Knowledge of KPI and its calculation, will be preferred.

Soft skills:

• Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.
• Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities.
• Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.

Experience in a CHC product and strategic development environment is essential. Previous experience leading a global organization including management of large multi-country budgets is essential.

• Excellent team-work and interpersonal skills
• Ability to work in cross-functional teams
• Excellent oral and written communication skills
• Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.

Technical skills:

• Ability to implement strategic efficiency and develop a strategic vision and operational aspects.
• Ability to evaluate transversal impact on business decision. Ability to provide the strategic vision and leadership to develop and drive strategic CHC sourcing related initiatives with clear objectives through the entire organization.
• Good knowledge on end-to-end Vendor and contract Management.
• Experience in building a functional capability from the ground-up highly valued. Proficient in International Regulations, Guidelines, Good Practices pertaining to the pharmaceutical industry standard and practices for medical and Pharmacovigilance.

Education:

Scientific background: Higher University level degree (L.L.B, JD, MBA) is mandatory. Basic education in Medical Science stream.

Languages: Fluent in English (verbal and written)