Medical Safety Specialist [Innovative Medicine]

2+ years

Not Disclosed

Remote, USA

10 Nov. 5, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Slug: medical-safety-specialist-innovative-medicine-pharmacovigilance-johnson-johnson

Medical Safety Specialist [Innovative Medicine]

Function: Product Safety
Sub-function: Pharmacovigilance
Location: Mongkok, Hong Kong S.A.R., China
Date Posted: October 7, 2024
Requisition Number: 2406216439W

About Johnson & Johnson:

At Johnson & Johnson, we believe that health is everything. Our passion for healthcare innovation empowers us to address the world’s most complex diseases, prevent illness, and deliver treatments that are smarter and less invasive. With expertise spanning across Innovative Medicine and MedTech, we are uniquely positioned to drive healthcare advancements and deliver the breakthroughs of tomorrow, today. Learn more about us at Johnson & Johnson.

For over 130 years, Diversity, Equity, and Inclusion (DEI) have been part of our core values, woven into our culture, and essential to our work. Rooted in our Credo, DEI fuels our pursuit of creating a healthier and more equitable world. We believe that by fostering a culture of inclusion and belonging, we can innovate better solutions and accelerate our impact on healthcare challenges.

Job Purpose and Scope:

We are excited to offer the role of Medical Safety Specialist within our Pharmacovigilance (Local Medical Safety) team based in Hong Kong. In this role, you will manage safety activities related to both medicinal and non-medicinal products, ensuring compliance with local regulations, company policies, and global safety standards. You will also contribute to the development of effective pharmacovigilance and risk management systems that support product oversight across local, regional, and global levels.

Key Responsibilities:

As a Medical Safety Specialist, your primary responsibilities will include:

Safety Reporting & Oversight:
- Ensure processes and systems are in place for the collection and reporting of safety data in accordance with local and global regulatory requirements.
- Oversee daily adverse event (AE) reporting and ensure timely and accurate submission.
- Review project documents (e.g., patient support programs, surveys, market research) to ensure potential AEs are appropriately documented and reported.
Regulatory Compliance:
- Monitor day-to-day pharmacovigilance (PV) activities to maintain compliance with local regulations and global requirements.
- Coordinate and manage safety requirements for Marketing Authorization Holders (MAH).
- Maintain oversight of safety audits and inspections at the local level.
- Track changes in regulatory requirements and assess the impact on local PV activities.
Signal Detection & Risk Management:
- Ensure local signal detection processes are followed, identifying and reporting potential signals or clusters of adverse events.
- Collaborate with other departments (e.g., Medical Affairs, Regulatory Affairs) to ensure timely implementation of Risk Management Plans (RMPs) and related activities.
- Review risk management plans, PSURs (Periodic Safety Update Reports), and other product safety documents to evaluate the product’s risk/benefit profile.
- Provide safety input during pre-authorization and submission phases, ensuring appropriate planning for RMP-related activities.
Business Relationships & Communication:
- Build and maintain effective relationships with internal and external stakeholders to facilitate communication and collaboration across the LOC.
- Communicate potential issues or changes in safety processes to global and regional teams.

Qualifications:

Education:

A Medical, Pharmacy, or Health Sciences degree is required, with expertise in pharmaceutical regulation.

Experience:

A minimum of 2+ years in Pharmacovigilance (PV) or Medical Safety, with prior experience in the pharmaceutical industry strongly preferred.
Experience in conducting audits and delivering training is highly valued.
Demonstrated attention to detail and strong decision-making ability.
Proven customer orientation and commitment to compliance with safety regulations and quality standards.
Ability to evaluate and assess the impact of actions on global PV systems and patient safety.

Other Requirements:

Strong communication skills in English and Cantonese are essential for interacting with regional and global teams, as well as Health Authorities.
Strong influencing and problem-solving skills to ensure patient safety while balancing regulatory compliance.
Demonstrated urgency and commitment to meeting deadlines and objectives.

What Awaits You at J&J:

Global Market Leadership: Be part of a global leader in healthcare innovation.
Dynamic Environment: Engage in a fast-paced, challenging work environment with opportunities to grow.
Career Development: Access to continuous personal and professional development.
Employee Benefits: Enjoy a variety of employee benefits, including flexible working hours, wellness support, a company gym, and corporate events.
Inclusive Culture: We support a culture of belonging where all employees can thrive.

Additional Information:

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, age, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

For more information about how we support our employees' health, wellness, and career growth, visit Johnson & Johnson Careers.

Ready to Apply?
Join our team and make an impact on global healthcare. Apply now to be part of the Johnson & Johnson family!