Associate Director Consumer Safety Regions, North America

Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve 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 its 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.

About the role

The Associate Director Consumer Safety Regions North America is responsible for day-to-day management of safety and vigilance activities for Haleon marketed products and those under development within the U.S market while providing regional coordination and support for North America. This includes ensuring strict compliance with all local U.S. regulations including pharmacovigilance cosmetovigilance materiovigilance and nutrivigilance and aligning these with company global standards.

Acting as the primary PV point of contact for U.S. this role ensures safety activities are executed at the country level while supporting the Director Consumer Safety Science & US/Canada Region with broader North America strategic initiatives and engaging with stakeholders 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 Operating Units and ensuring compliance with regulatory requirements.

This is a full-time flexible hybrid position requiring 3 days per week in-office reporting to Haleons Warren NJ office.

Key Responsibilities:

• Safety Regional Country Contact (SRCC)/Nominated PV contact to local health Authority or person responsible for pharmacovigilance for the United States.

• Monitor compliance with the requirements of company industry and local regulatory authority etc. coordinate and contribute to the development and implementation of relevant PV initiatives and plans.

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

• RMPs and DHCPL coordination including stakeholder engagement and contact with local authorities as required

• Oversight of all country specific safety matters/activities related to Haleon products and related to designated clinical trials and post-marketing requirements in accordance with international and local legal and regulatory requirements and guidelines

• Ensure pharmacovigilance training is implemented for all partners and relevant 3rd parties as required

• Negotiates PV Agreement terms for local licensing agreements in conjunction with Legal and Regulatory Affairs

• Provides support and coordination for all 3rd Partys due diligence for new local deals from medical perspective. To monitor its practice performance in PV management requirements on a regular basis.

• Provides consultation and Human Safety Information/Adverse Event clause for local contracts other than PVAs

• Provides integrated strategic safety expertise to local commercial programs and clinical development program etc.

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

• Ensures appropriate management monitoring of PV activities for Haleon Products within the North Americas region

• Constantly maintain inspection readiness for PV Medical Device and GCP audits and inspections; takes part in the preparation and conduct of PV/MD inspections/audits ensures timely execution and submission of responses to findings and maintains inspection documents relevant to Consumer Safety activities.

• Key point of contact for Internal PV audits and external local Regulatory Authority inspections as needed

• Lead/support regional or global Consumer Safety departmental initiatives for Haleon interacting with other key stakeholders as required.

• Support to oversee the outsourced vendor model to ensure robust compliance program company policies and standard operating procedures and ensure compliance with regulatory standards fit for the business.

• Maintains an awareness of developments in the safety profiles of the company products and has an up-to-date overview of status of the safety profiles and emerging safety concerns for the Region.

Why you

Basic Qualifications:

• Bachelors degree in Nursing Pharmacy Medical Life Sciences or equivalent.

• 7 years of experience in the pharmaceutical or consumer healthcare industry including extensive time spent on pharmacovigilance quality or other relevant functions.

• Experience with local regulatory environment and knowledge of Pharmacovigilance and/or Materiovigilance Cosmetovigilance and Nutrivigilance regulator and business 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.

• Direct experience supporting FDA inspections and internal PV audits.

• 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.

• Experience working in global matrixed teams and management of outsourced partnerships

Preferred Skills:

• Advanced degree: Pharm D Masters degree in relevant clinical or scientific field.

• Direct experience in Materiovigilance Cosmetovigilance and/or Nutrivigilance.

• Prior experience supporting or leading Medical Device and/or GCP audits and inspections including inspection readiness and responses to findings.

• Strong ability to manage multiple priorities in a fastpaced environment with high attention to detail and regulatory rigor.

Compensation: The salary range for this role is:$156313 - $214930 plus a 18% on-target bonus.

Location: This role is based in based in Warren NJ and follows a hybrid model requiring an in-office presence of 3 days per week.

#Li-Hybrid

Benefits

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan tuition reimbursement and time off programs including 6 months paid parental leave. On day one you are eligible for benefits including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.

Job Posting End Date

Equal Opportunities

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. Its 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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license Haleon may be required to capture and report expenses Haleon incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleons compliance to all federal and state US Transparency requirements.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process please contact us by sending an email to Please include the following in your email:

Use subject line: Haleon Careers: Job Accommodation Request

Your Name and contact information

Requisition ID and Job Title you are interested in

Location of Requisition (city/state or province/country)

Description of specific accommodation you are requesting

Please note: Resumes CVs or other requests outside of accommodation support submitted to this email box will not be accepted.

Note to candidates

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