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- Tasks: Manage local pharmacovigilance systems and ensure compliance with safety regulations.
- Company: Join Johnson & Johnson, a leader in healthcare innovation dedicated to improving global health.
- Benefits: Enjoy a full-time role with opportunities for growth and development in a dynamic environment.
- Why this job: Make a real impact on health while working in a collaborative and innovative culture.
- Qualifications: 2+ years in the pharmaceutical industry with a focus on pharmacovigilance required.
- Other info: Flexible application options available based on experience level.
The predicted salary is between 42000 - 84000 £ per year.
Join to apply for the Local Medical Safety Specialist role at Johnson & Johnson Innovative Medicine
Join to apply for the Local Medical Safety Specialist role at Johnson & Johnson Innovative Medicine
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At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com
Job Function
Product Safety
Job Sub Function
Pharmacovigilance
Job Category
Scientific/Technology
All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom
Job Description
Purpose
Local Medical Safety (LMS) ensures pro-active Benefit Risk Management throughout product life cycle by translating global safety data to insights and actions, and tailoring to local specificities and needs.
We support activities related to the pharmacovigilance regulatory requirements of Marketing Authorization Holders (MAH) and/or study sponsors, as applicable.
Please note that this role is available with the same job title, but different levels of experience. While you are welcome to apply to any or all of the postings, we recommend focusing on the experience that aligns with your profile.
2+ years of experience – R-020042
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
You Will Be Responsible For
Ensuring the local Pharmacovigilance (PV) system is managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any PV agreements with third party business partners.
Conducting local benefit-risk activities to ensure pro-active benefit-risk management throughout the product life cycle.
ICSR MANAGEMENT AND OVERSIGHT
Ensuring local collection, review, reporting, reconciliation, and follow up of Individual Case Safety Reports (ICSR) and implementation of the local literature process.
Maintain active involvement in day-to-day ICSR management related activities as applicable, and Maintain oversight of corresponding vendor activities as required.
Aggregate reports
Leading Preparation, review, tracking and timely submission of aggregate reports to all relevant local authorities or other official bodies, where applicable.
Local Safety compliance
Providing insights into ICSR inbound and outbound compliance metrics, perform ICSR reconciliations and leading actions as needed. Acting as a CAPA content owner and subject matter expert, owning actions as required. Performing or overseeing procedural document review and improvement, conducting impact assessments as required on local level and support implementation of Global PV relevant documents as applicable.
Responsible for timely provision of high quality and accurate contributions to PSMF, as required.
Ensure LOC and LSU audit and inspection readiness.
Safety regulations
Ensure awareness and participate in the review of new/revised safety regulations, evaluating impact on local / global processes and notifying appropriate global and regional groups of changes as appropriate. Actioning implementation of new legislation with local impact for LMS-owned activities.
Maintain focused engagement in local industry associations and drive local policy shaping initiatives based on One J&J Voice.
PHARMACOVIGILANCE SERVICE PROVISION
Ensure that day-to-day PV activities and safety activities for medicinal and non-medicinal products (i.e., medical devices) are performed satisfactorily. Collaborating with the local Marketing Authorization Holder (MAH) to enable fulfilment of its regulatory responsibilities and meet their business objectives.
Provide timely and accurate EU Pharmacovigilance System Master File (PSMF) contributions and ensure adequate process is established for the implementation and the maintenance of the local “PSMF”, as applicable.Communicate with the HA, when applicable, to clarify requirements in support of LMS-wide policy, process harmonization/improvement.
Ensure business continuity to safeguard compliance.
Provide support to the Related Research Activities Center of Excellence (RRA CoE) for local Related Research Activities (RRA).
Collaborate with project owners and LMS operations to provide input for the reporting process of potential AEs included in local data generating activities to ensure appropriate safety monitoring.
PV contract management
Leading pharmacovigilance agreement (PVA) reviews, assisting with managing local PVAs, and ensuring local oversight and implementation, including local safety unit (LSU) training and adherence to PVAs. Coordinating the provision of support for third party safety agreements locally e.g. local Vendor Agreements, liaising with central functions, and providing ongoing oversight to ensure safety obligations are met.
Providing and/or reviewing listings for the pharmacovigilance system master file (PSMF) for agreements signed by the LOC ensuring accuracy and timeliness.
Local Communications
Ensure proper handling of Health Authority (HA) safety related queries (communication, response, and escalation). Working with Regulatory Affairs to forward any safety-related inquiry or relevant communication to the appropriate regional and global groups as appropriate. Supporting the Qualified Person to provide safety-related regulatory communications where required.
PV-Safety training support
Performing training for LOC employees covering Pharmacovigilance, safety aspects of products, and managing AE/PQC trainings to distributors and vendors.
Benefit Risk Management
Establishing product knowledge with focus on safety profiles, and Therapeutic Area and Disease Pathway knowledge to support the needs of the local Medical and Marketing organization in collaboration with Global Medical Safety (GMS).
Acting as local safety expert in cross-functional team meetings and performing training on safety relevant aspects, as appropriate. Participating in discussion and evaluation of topics related to benefit risk and product safety as required, and have involvement in local safety signal detection, if applicable.
Leading preparation of local Risk Management Plans (RMPs)/RMP Addendums. Involvement in implementation of RMPs, Urgent Safety Restrictions, and Dear Healthcare Professional Communications management as required.
Performing concept and protocol review related to data generation activities, and providing input into safety sections of local protocols (such as Clinical Trials, Non-Interventional Studies, Related Research Activities, Patient Support Programs etc.) to ensure appropriate safety reporting as required by regulations.
Performing medical/ pharmaceutical assessment of local individual cases when requested and in partnership with global teams if applicable, and undertaking appropriate actions such as site visits for special interest cases as requested.
Qualifications/Requirements
Essential Knowledge & Skills
- Scientific/ life-science background, medicinal knowledge preferred; proficiency in Medical terminology.
- Ability to handle multiple critical issues.
- Computer literate with basic knowledge of GMS database systems.
- Awareness of and familiarity with industry principles of drug development and pharmacology.
- Proficiency in global and local SOPs.
- Good verbal and written communication skill
- Ability to negotiate and communicate with internal and external customers.
- Ability to establish and maintain open relationships within the organisation and with authorities.
- Demonstrable knowledge of all local PV requirements and of global aspects of drug safety.
Experience
- Scientific study and experience in pharmaceutical regulations and R&D processes.
- 4-6years Pharmaceutical industry experience including a PV responsibility role required.
Seniority level
-
Seniority level
Not Applicable
Employment type
-
Employment type
Full-time
Job function
-
Job function
Management and Manufacturing
-
Industries
Pharmaceutical Manufacturing
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Local Medical Safety Specialist employer: Johnson & Johnson Innovative Medicine
Contact Detail:
Johnson & Johnson Innovative Medicine Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Local Medical Safety Specialist
✨Tip Number 1
Familiarise yourself with the latest pharmacovigilance regulations and guidelines. Understanding local and global compliance requirements will not only boost your confidence during interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those working in pharmacovigilance. Attend relevant conferences or webinars to make connections and gain insights that could give you an edge in your application.
✨Tip Number 3
Prepare to discuss specific case studies or examples from your previous experience that highlight your ability to manage safety reports and compliance metrics. This will showcase your practical knowledge and problem-solving skills.
✨Tip Number 4
Stay updated on current trends in medical safety and drug development. Being knowledgeable about recent advancements can help you engage in meaningful conversations during interviews and show your passion for the field.
We think you need these skills to ace Local Medical Safety Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you thoroughly understand the responsibilities and requirements of the Local Medical Safety Specialist position. Tailor your application to highlight how your experience aligns with the specific tasks mentioned in the job description.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in pharmacovigilance and any relevant roles you've held in the pharmaceutical industry. Use specific examples to demonstrate your knowledge of local and global safety regulations.
Craft a Strong Cover Letter: Your cover letter should not only express your enthusiasm for the role but also explain why you're a perfect fit. Mention your scientific background and any specific skills that relate to the job, such as your ability to manage Individual Case Safety Reports (ICSRs).
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in a role focused on safety and compliance.
How to prepare for a job interview at Johnson & Johnson Innovative Medicine
✨Know Your Pharmacovigilance Basics
Make sure you have a solid understanding of pharmacovigilance principles and local regulations. Brush up on your knowledge of Individual Case Safety Reports (ICSRs) and how they fit into the broader context of product safety management.
✨Demonstrate Your Communication Skills
As a Local Medical Safety Specialist, you'll need to communicate effectively with various stakeholders. Prepare examples of how you've successfully communicated complex information in the past, whether to colleagues or external partners.
✨Showcase Your Problem-Solving Abilities
Be ready to discuss specific instances where you've tackled critical issues in a fast-paced environment. Highlight your ability to manage multiple priorities while ensuring compliance with safety regulations.
✨Familiarise Yourself with Johnson & Johnson's Values
Research Johnson & Johnson's commitment to health and innovation. Be prepared to discuss how your personal values align with theirs and how you can contribute to their mission of improving health outcomes.
