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**Job Function: **
Product Safety
**Job Sub Function: **
Pharmacovigilance
Job Category:
Scientific/Technology
All Job Posting Locations:
Ho Chi Minh, Hồ Chí Minh, Vietnam
Job Description:
General Job Duties and Responsibilities
- Accountable to ensure and maintain oversight on Local Operating Company (LOC) pharmacovigilance (PV) systems and processes in collaboration with appropriate
functions and stakeholders:
- Ensure that the Local Pharmacovigilance system is managed in compliance with local regulations and company policies/procedures at a local, regional and global level and
in accordance with any PV agreements with third party business partners.
Ensure to have in place an appropriate system for Risk Management to assure oversight for products within its responsibility.
Manage related local benefit risk activities to ensure pro-active benefit-risk management throughout product life cycle
Engage with internal stakeholders as the representative of Global Medical Safety (GMS)
Communicate with local HAs where applicable
Foster external engagements compliant with local regulations.
Ensure LOCs business needs related to PV are maintained with the local key stakeholders and external stakeholders
ICSR Management and Oversight
Ensure collection, review, reporting, reconciliation and follow-up of Individual Case Safety Reports (ICSR) compliant with local regulations and global procedures
Maintain oversight of day-to-day ICSR management related activities as applicable
Ensure implementation of local literature process
Maintain oversight of corresponding vendor management, as applicable.
Ensure maximization of vendor support utilization for LSU activities, as per LMS-wide strategy and agreements.
PV Compliance Activities
- Maintain overall responsibility for the coordination of safety requirements as delegated by Marketing Authorization Holders (MAH) and will report out on compliance and risk
indicators to applicable MAH/LMS meetings
Ensure PV audit/inspection readiness at the LOC at all times.
Act as the local PV contact person for internal PV audits and external PV inspections
Facilitate inspectors/auditors activities and provide support for audit/inspection document requests
Maintain oversight of ICSR inbound and outbound compliance
Maintain oversight of ICSR reconciliations and compliance dashboards in cooperation with Medical Safety Quality (MSQ) and Related Research Activity Center of Excellent (RRA COE).
Increase and maintain PV compliance awareness and business relevance with stakeholders and ensure appropriate ownership of PV-related findings and Corrective
Action/Preventive Actions (CAPAs).
Address follow-up actions from Local Safety unit (LSU) owned non-conformances, including LSU related CAPAs
Connect with the EU QPPV and delegates to raise any potential compliance or safety issues independently of reporting lines.
Where applicable, support the QPPV and Regulatory Affairs with the nteractions with the Local Health Authorities.
Escalate compliance issues in a timely manner to Regional Safety Head and ensure appropriate mitigation is implemented
Ensure compliance with own training curriculum
Aggregate reporting
- Oversight on local review, translation (if applicable), preparation, submission, and tracking of 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
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 (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.
Provide safety training as requested to maintain awareness of safety reporting as required.
Manage AE/PQC training to distributors/vendors and translation of AE/PQC training material, where needed.
LOCAL BENEFIT-RISK ACTIVITIES
Medical Safety Insights
Demonstrate full product portfolio insight with local prioritization focus,
Lead and support LSU to establish Product knowledge with focus on safety profiles, Therapeutic Area (TA) and Disease Pathway knowledge, supporting the needs of the local Medical and Marketing organization, in collaboration with the Risk management
Lead (RML) and LMS product team as applicable.
Support LSU to participate in the TA and Product cross-functional teams to contribute safety insight for strategy development, as appropriate,
Act as a safety expert in team meetings, deliver proactive LMS strategy, perform training on product safety relevant aspects, as appropriate, provide support to LMS product teams.
Local product compliance related Activities
Conduct the local product compliance related activities in collaboration with stakeholders
Communicate new relevant safety information available in a timely manner to GMS internal stakeholders and to local internal LOC stakeholders as per procedure
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.
- Preparation of local RMP/Addendums based on internal alignment and local/global procedures as required.
Local PV Responsible/ Local QPPV
Act as local nominated contact for PV
Describe the role of legal local PV responsible person as defined by national law. (when applicable)
Add responsibilities as back-up LSO here as applicable
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 required business language(s)
Ability to effectively communicate and negotiate with internal and external customers.
Ability to establish and maintain open 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,
proved knowledge and confidence with the legislative environment”
Must be able to work independently with minimum supervision while meeting tight deadlines.
People Leadership experience (for people manager) is preferred
Experience
Healthcare or pharmaceutical sciences with 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:
Analytical Reasoning, Clinical Operations, Coaching, Collaboration, Cross-Functional Collaboration, Detail-Oriented, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Root Cause Analysis (RCA), Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Technologically Savvy