About the position
General Job Duties and Responsibilities
General Job Duties and Responsibilities
Tasks may include (please indicate which areas do apply):
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ICSR MANAGEMENT AND OVERSIGHT
· Ensure local collection, review, reporting, reconciliation, and follow up on 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.
· Maintain oversight of corresponding vendor activities as required.
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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
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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.
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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.
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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 (PVA’s)
· 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
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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.
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
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 (Minimum/preferred years of experience can be adapted appropriately)
A minimum of 2 + years pharmaceutical industry experience with at least 1 year in a product vigilance
Case processing responsibility role
Desired Skills:
- Product knowledge
- Compliance
- Good communication
- team collaboration
