Senior Specialist, Local Medical Safety

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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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

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.

Essential Job Duties and Responsibilities - 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

• Ensure local collection review reporting reconciliation and follow up of Individual Case Safety Reports (ICSR).

• Manage and maintain active involvement in day-to-day ICSR management related activities as applicable ensure implementation of local literature process and maintain oversight of corresponding vendor activities as required.

COMPLIANCE ACTIVITIES

• Ensure PV audit/inspection readiness at the LOC level at all times.

• Maintain oversight of ICSR inbound and outbound compliance.

• In cooperation with Medical Safety Quality (MSQ) perform ICSR reconciliations and review compliance dashboards from MSQ for accuracy.

• Increase PV compliance awareness and business relevance with stakeholders and ensure appropriate ownership of PV-related findings and Corrective Action/Preventive Actions (CAPAs).

• Escalate compliance issues in a timely manner to Country/Cluster Safety Head (CSH) to ensure appropriate mitigation is implemented.

• Address follow-up actions from Local Safety unit (LSU) owned non conformances including LSU related CAPAs.

AGGREGATE REPORTING

• Review translate (if applicable) prepare submit and track aggregate reports as required by local regulations and ensure compliance oversight requirements are met.

• Support the preparation of aggregate reports and provide due dates to Global Medical Safety (GMS) and promoting synchronization with the Global Aggregate reporting schedule in accordance with local regulatory requirements and in collaboration with the local Regulatory Affairs unit.

LOCAL REGULATORY REQUIREMENTS

• Ensure awareness of new/changes in local PV regulations and evaluation of the impact on local/global processes and notification of appropriate local regional and global groups.

• Perform procedural document impact assessment and support implementation of Global PV relevant Procedural Documents as applicable.

• Implement new or updated PV regulations as needed.

• Provide input into requests for information in support of the development of LMS-wide processes systems and policies.

• Engage 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.

• Collaborate with the local Marketing Authorization Holder (MAH) to enable fulfilment of its regulatory responsibilities and meet their business objectives.

• Manage and implement local Pharmacovigilance Agreement (PVAs)

• Support activity owners in including appropriate PV language in vendor contracts to ensure safety obligations are met as applicable.

• 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.

• Ensure proper handling of Health Authority (HA) safety related queries (communication response and escalation).

• 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.

TRAINING

• Support global roll out AE/PQC training in LOC.

• Provide safety training to maintain awareness of safety reporting as required.

• Manage AE/PQC training to distributors/vendors and translation of AE/PQC training material where needed.

• Ensure compliance with own training curriculum.

LOCAL BENEFIT-RISK ACTIVITIES

Medical Insights

• Establish Product knowledge with focus on safety profiles Therapeutic Area (TA) and Disease Pathway knowledge supporting the needs of the local Medical and Commercial organization in collaboration with the Risk Management Leads and LMS product team as applicable.

• Participate in the TA and Product local cross-functional teams to contribute safety insight for strategy development act as a safety expert in team meetings communicate relevant safety information for LOC stakeholders and perform training on safety relevant aspects as appropriate.

• Participate in LMS product teams as applicable.

Local Product Compliance Related Activities

• Conduct the local product compliance related activities in collaboration with stakeholders such as Medical Safety Officers (MSO) as needed.

• Communicate new relevant safety information available in a timely manner to GMS and to LOC stakeholders as per procedure.

• Involvement in local safety signal detection if applicable.

• Support internal discussion of Risk Management Plans (RMPs)/Addendums with local stakeholders participate in local implementation of RMP including additional risk minimization activities and negotiate with local HA to reach agreement etc. as applicable.

• Prepare local RMP/Addendums based on internal alignment and local/global procedures as required.

• Support implementation of Company Core Data Sheet (CCDS) into local label (Summary of Product Characteristics (SmPC) patient Leaflet etc) as applicable.

OTHERS

• Participate or lead LMS projects and initiatives locally regionally and globally.

• Be an ambassador of the Local Medical Safety mission and vision.

• As locally applicable please add country specific required responsibility here.

Minimum Qualification

• A degree in life health or pharmaceutical sciences is preferred proficiency in Medical terminology.

• Excellent verbal and written communication skills

• Fluency in the national language(s) and the English language required

• Ability to effectively communicate and negotiate with internal and external customers. Ability to establish and maintain relationships within the organization and with authorities.

• Excellent analytical skills to identify gaps and root causes of issues and think out of the box to develop a solution.

• Excellent computer proficiency e.g MS Office

• Proficiency in global and local Standard Operating Procedures (SOPs)

• Must be able to work independently with minimum supervision while meeting tight deadlines.

Experience

• Scientific study and experience in pharmaceutical regulations and R&D processes.

• By preference a minimum of 5 years pharmaceutical industry experience with at least 1 year in a product vigilance responsibility role.

Required Skills:

Preferred Skills: