Local Medical Safety Specialist, UK & Ireland

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:

We are searching for the best talent for a Local Medical Safety Specialist/ Back-up Local Safety Officer for the UK & Ireland, to be based in High Wycombe, UK.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow!

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

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.

You will be responsible for:

Back-up Local Safety Officer (LSO)

As a back up of the Local Safety Officer for UK and Ireland, collaborating to ensure that day-to-day Pharmacovigilance activities and safety activities for medicinal products and medical devices are handled and performed satisfactorily, whilst maintaining regulatory compliance at Local Operating Company (LOC) level.

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.

Safety regulations

Participating in the review of new/revised safety regulations, evaluating impact on local 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.

Local Safety compliance

Providing insights into metrics 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.

Responsible for timely provision of high quality and accurate contributions to PSMF, as required.

Ensure LOC and LSU audit and inspection readiness.

PV contract management

Acting as LMS lead pharmacovigilance agreement (PVA) reviewer, 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.

Providing and/or reviewing listings for the pharmacovigilance system master file (PSMF) for agreements signed by the LOC ensuring accuracy and timeliness.

Local Communications

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.

Aggregate reports

Supporting the LSO to provide medical input and insights for aggregate reports, undertaking local review and ensuring the timely submission of aggregate reports to all relevant local authorities or other official bodies, where applicable.

PV-Safety training support

Performing training for LOC employees covering Pharmacovigilance, safety aspects of products, and managing AE/PQC trainings to distributors and vendors.

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.
• Pharmaceutical industry experience including a PV responsibility role required.