Job description

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity.
Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.
Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

Job Purpose:

A Consumer Safety role responsible for oversight in various MEA markets. The role assists with strategizing and engaging with key Haleon functions that integrate with Consumer Safety. The position holder is responsible for ensuring compliance with PV requirements, interactions with regulators and bodies of influence and industry best practices

Job Related Experience:

The Associate Director, CS Europe, MEA & LATAM is a Consumer Safety role responsible for covering multiple highly complex markets with stringent pharmacovigilance, cosmetovigilance, materiovigilance and nutrivigilance regulations and assuming direct responsibility for a cluster of markets.

This role acts as the PV point of contact for consumer healthcare responsible for all safety activities at the country level.

The role is responsible for assisting the Consumer Safety Director Europe, MEA & LATAM with strategy, engaging with Haleon teams associated within (but not limited to) pharmacovigilance, cosmetovigilance, materiovigilance and nutrivigilance, clinical research, Market Research, Patient Support Programs, Interactive Digital Media, Sensory Studies and/or local operating companies (LOCs), and ensuring compliance with regulatory requirements and industry best practices.

ACCOUNTABILITIES/RESPONSIBILITIES

The primary responsibilities of this role are to:

• Overall responsibility for the day-to-day management of vigilance for marketed products (including Medicinals, cosmetics, devices and nutritionals) and products in clinical trials for Consumer Healthcare local markets assigned to the region. Responsibilities include the following:

  
  
  

• Ensure compliance with all local and global vigilance regulations for countries under the assigned responsibility.

  
  
  

• Acts as Local Qualified Person responsible for Pharmacovigilance (LQPPV) for Egypt.

  
  
  

• Acts as Safety Regional country contact for Middle East and Africa (MEA) countries in scope.

  
  
  

• Perform Quality Control activities (in stream check, Management Monitoring), according to global standards and local procedures.

  
  
  

• Provide robust monitoring of local regulations of all assigned countries.

  
  
  

• Responsible for Pharmacovigilance training to all Country departments and relevant 3rd parties.

  
  
  

• Ensure English translations of all required safety documentation, including cases received directly from Central Safety functions.

  
  
  

• Negotiates Safety Data Exchange procedures for local licensing agreements in conjunction with Legal and Regulatory Affairs.

  
  
  

• Provides support and coordinate 3rd Party’s PV due diligence for new local deals in the region.

  
  
  

• Provides consultation and Human Safety Information/Adverse Event clause for contracts other than SDEAs.

  
  
  

• Provides safety support to local commercial programs and clinical development programs, etc.

  
  
  

• Ensures Human Safety Information reporting compliance of Digital, Market Research and Patient Support Program providers.

  
  
  

• Maintaining up to date local product list and contact list for assigned countries.

  
  
  

• Support local literature journal list review as appropriate

  
  
  

• Escalations management (litigation, media attention, safety signals) and Inspections, Audits support and coordination

  
  
  

• DHCPL (Dear HealthCare Professional Letters), DIL (Dear Investigator Letters) submission to local health authority as required.

  
  
  

• Preparation and submission of local PSMF where required.

  
  
  

• Lead/support Consumer Safety process improvement initiatives for Haleon, interacting with other key stakeholders, as required.

  
  
  

• Contribute to the PSMF and co- drive continuous improvement of the vigilance system and its performance

  
  
  

Why you?

Qualifications & Skills

• Bachelor’s degree in Pharmaceutical Sciences or medicine.

  
  
  

• Good knowledge of Regulatory and Pharmacovigilance regulations.

  
  
  

COMPETENCIES AND SKILLS:

• 7+ years’ of experience in a pharmaceutical industry including extensive time spent in industry (pharmacovigilance, quality, or other functions).

  
  
  

• 4+ years’ experience as QPPV for Egypt.

  
  
  

• Residency in Egypt

  
  
  

• Knowledge of pharmacovigilance and clinical safety procedures / systems / guidance and general understanding of worldwide regulatory requirements.

  
  
  

• Excellent oral and written communication skills including the ability to listen effectively, persuasive negotiation skills, coalition building, conflict management and ability to communicate both strategic and technical issues to individuals and in presentation groups.

  
  
  

• Strong organizational and facilitation skills, both working as an individual contributor and as a function leader to provide decisions with sense of perspective and balance.

  
  
  

• Strong ability to work on contracts and material of contractual obligations including drafting & reviewing of PV agreements

  
  
  

• Extensive experience in pharmacovigilance audits, internal and/or external at both local & global levels. Ensuring the timely execution & submission of audit requests and findings.

  
  
  

 Job Posting End Date

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong.
During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. 
The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.

If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence. 

The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.