Specialist Consumer Safety Regions, APAC at Halborn

Minato-ku, Tokyo, Japan

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor’s degree in Healthcare or Pharmacy degree, pharmaceutics or life/biological sciences is preferred
Experience with Safety & PV Database and PV methodology
Experience working with the principles of data collection, manipulation and retrieval
Experience in medical device vigilance activities is preferred
Experience in the field of Pharmacovigilance and drug safety as required
Good understanding of Japan regulatory environment and Knowledge of Pharmacovigilance, regulator and business requirements
Understanding of diversity of Consumer Health businesses and local regulations for cosmetics, medical devices, and nutraceuticals
Proven ability to influence and negotiate with key internal and external stakeholders
Fluent oral and written English communication

Responsibilities

Support Safety Regional Country Contact (SRCC)/Anseki role when required to ensure PV and consumer safety compliance in Japan
Supports Human Safety Information (HSI)/ Adverse event collection from consumers and all other sources related to Haleon Healthcare marketed products and investigational products in clinical trials in accordance with international and local regulatory requirements and guidelines
Coordinates the timely submission to local competent regulatory authority for safety/ vigilance documents
Maintains up to date local product list and contact list for countries in region
Supports local literature searches/ journal list review as appropriate
Supports appropriate Safety Vigilance training and GVP training to Haleon Japan employees and 3rd party staffs when needed
Supports Dear HealthCare Professional Letters (DHCPL), Dear Investigator Letter (DIL) submission to local HA if applicable
Provides expertise to support SRCC/local QPPV to ensure internal audit and HA PV inspection readiness
Supports regular GVP SOP update and implementation
Provides consultation and Human Safety Information/Safety clause for local contracts other than PVAs
Ensures Human Safety Information reporting compliance of Digital, Market Research and Patient Support Program for local projects
Supports Internal PV audits and external local Regulatory Authority inspections as needed
Supports to ensure the Japan Signal case processing activities are completed in accordance with Haleon standard and regulatory requirements
Provides close monitoring of local regulations and product safety alerts for Haleon portfolio within the country and escalate identified safety concern/safety issue to SRCC timely
Supports the PV/Consumer safety activities in other countries within APAC region, when applicable
Supports regional and global process Consumer Safety improvement initiatives for Haleon, interacting with other key stakeholders, as required

Skills

Key technologies and capabilities for this role

PharmacovigilanceCosmetovigilanceDevice VigilanceNutrivigilanceRegulatory ComplianceAdverse Event CollectionGVPLiterature SearchingSafety TrainingAudit ReadinessRegulatory Submissions

Questions & Answers

Common questions about this position

What qualifications are required for this role?

A Bachelor’s degree in Healthcare or Pharmacy degree, pharmaceutics or life/biological sciences is preferred, along with experience with Safety & PV Database and PV methodology, and experience working with the principles of drug safety.

Is this a remote position or does it require being in a specific location?

This information is not specified in the job description.

What is the salary or compensation for this position?

This information is not specified in the job description.

What regions does this role cover?

The role is primarily responsible for Japan and supports regional assignments for other countries in APAC when needed.

What experience makes a strong candidate for this position?

Candidates with a degree in healthcare, pharmacy, or life sciences, plus hands-on experience with pharmacovigilance databases, methodologies, and principles of drug safety will stand out.

Halborn

Cybersecurity for blockchain and digital assets

About Halborn

Halborn specializes in cybersecurity focused on blockchain technology and digital assets. The firm provides security audits, penetration testing, and consulting services to clients in the digital finance sector, including cryptocurrency exchanges and Decentralized Finance (DeFi) companies. Their services help ensure the security of digital assets and financial infrastructure by addressing the specific security threats associated with blockchain technology. Halborn stands out from competitors due to its deep understanding of both blockchain and traditional financial security, which allows them to offer tailored solutions. The company's goal is to protect businesses from security threats, ensuring the safe operation of digital exchanges and the integrity of smart contract infrastructure.

Miami, FloridaHeadquarters

2019Year Founded

$87.5MTotal Funding

SERIES_ACompany Stage

Cybersecurity, Financial ServicesIndustries

51-200Employees

Benefits

Health Insurance

Unlimited Paid Time Off

Company Equity

Risks

Increased targeting of Bitcoin hot wallets poses risks to Halborn's clients.

AI-powered social media bot farms could introduce new cyber threats.

Ongoing vulnerabilities in smart contracts remain a challenge for Halborn's services.

Differentiation

Halborn specializes in blockchain and digital asset cybersecurity, setting it apart.

The company offers high-level security audits and penetration testing for DeFi clients.

Halborn's expertise in both blockchain and traditional finance security is unique.

Upsides

Growing demand for blockchain security boosts Halborn's market potential.

Partnerships with Tholos and Orion Protocol enhance Halborn's Web3 security reputation.

Tokenized real-world assets present new opportunities for Halborn's security solutions.

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