Local Medical Safety Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

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