Associate Director Consumer Safety Regions, North America

Haleon • Warren Township, NJ

20h • Hybrid

About The Position

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 Haleon’s Warren, NJ office.

Requirements

• Bachelor’s 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.

Nice To Haves

• Advanced degree: Pharm D, Master’s 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 fast‑paced environment, with high attention to detail and regulatory rigor.

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 Party’s 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 America’s 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level