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.