COUNTRY SAFETY TEAM LEAD, SOUTH ASIA

Ensuring that the Local Operating Company (LOC) safety activities, related to medicinal products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any Pharmacovigilance (PV) agreements with third party business partners.
Having appropriate pharmacovigilance risk management systems and adequate record management in place to assure appropriate oversight for products within its responsibility.
Managing Local Medical Safety activities to.
Ensure proactive Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs.
Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.
Managing and coaching Local Medical Safety Team staff.
Serving as a member of the Asia-Pacific (APAC) IPV Leadership Team.
Providing strategic leadership of the territory cluster and supporting LOC(s) to meet all global, regional, and local PV responsibilities.
Participating and leading International Pharmacovigilance (IPV) projects and initiatives locally and regionally within APAC cluster.
Participating (and may lead) in IPV regional projects and initiatives and providing a supportive role in IPV global projects and initiatives.
Principal Responsibilities 1.
Act as Local Nominated Person (including back-up nominated person) Act as locally nominated person for Pharmacovigilance (PV) assuming the PV role as defined by national law/regulation.
Collaborate with the Qualified Person for Pharmacovigilance (QPPV) offices as required.
Represents the company as the Pharmacovigilance Officer in-charge for India 2.
Oversight of the PV System & Overall responsibilities Oversight of the applicable product portfolio, and link with local management and key stakeholders.
Maintain oversight of all required PV regulatory reporting compliance in a timely manner.
Provide insights into metrics and lead actions as needed.
Ensure that day-to-day PV functions are performed satisfactorily, and that full regulatory compliance is maintained at LOC level including adequate record management.
Collaborate with the local MAH to enable fulfilment of its regulatory responsibilities [including Pharmacovigilance Agreement (PVA)] and meet their business objectives.
Advise the local business on the PV impact of local organized data collection programs.
Escalate compliance issues in a timely manner to Regional Safety Head, APAC, to ensure appropriate mitigation is implemented.
Monitor and forecast PV workload to identify, mitigate and escalate potential PV resource and non-compliance issues.
Identify periods of high PV workload and manage PV resource appropriately to address them.
Support and lead process improvements to optimize the PV system and make best use of PV resource.
Work collaboratively with regional affiliates to ensure consistency of approach across groups.
Build and maintain effective business relationships across the LOC to support the implementation of safety standards.
Provide high quality and consistent input to development of local safety initiatives and programs.
Plan and deploy skilled resources against project priorities, if applicable Maintain an environment of continuous improvement within the PV team and contribute to continuous improvement initiatives across the region and globally with Global Medical Organization (GMO) and Global Medical Safety (GMS).
Oversight and maintain the International PV (IPV) Pharmacovigilance System Master File (PSMF) and responsible for the local PSMF implementation and maintenance, as applicable.
Collaborate with local/cluster Case Management team to ensure LOC/Local Safety Unit (LSU) audit and inspection readiness at all times.
Act as Corrective Action/Preventive Action (CAPA) Content owner and subject matter expert, own actions as required.
Perform review of procedural documents from Subject Matter Experts 3.
Safety Management & Reporting Case management & Health Authority (HA) reporting o Ensure that local processes, procedures, and systems are in place for collection (initial and follow-up), review, tracking, processing, reporting, reconciliation and follow up of Adverse Events (AEs), Adverse Events combined with Product Quality Complaints (AE+PQCs), pregnancy, all other special situation reports and any other safety information reportable to GMS from any sources.
o Maintain oversight on day-to-day AE inbound and outbound reporting as applicable.
o Accountable for ensuring that the LOC meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
o Establish adequate collaboration with Case Management team to maintain local compliance oversight on case processing, follow up requests, reconciliation, local medical or scientific literature search, which are not included in global literature review, and submission to local HA.
Translation o Ensure in collaboration with Case Management team translation of Individual Case Safety Reports (ICSRs), Periodic Benefit Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs), HA correspondence, regulatory intelligence, as required.
Aggregate reporting o Collaborate with Case Management team, as applicable, in planning and ensuring timely submission of Aggregate Reports according to local regulations.
o Establish adequate collaboration with the Case Management team, as applicable, to provide local data as required to support the preparation of Aggregate Safety Summary reports (PBRER/PSUR, DSUR, etc.), undertake local review and submission of PBRERs/PSURs, provide due dates to GMS and promote synchronization with the Global PSUR schedule, in accordance with local regulatory requirements.
o When applicable, for “Products for Local Opportunity” (POLOs), when GMS does not provide the Aggregate Reports, ensure the specific reports (e.
.
PSUR) are prepared if not already provided by a third party under a PVA.
Research Related Activities (RRAs) o Oversight of data generating activities to ensure appropriate review and reporting processes are included in project documents for reporting potential AEs (e.
.
patient support programs, market research surveys, internet sites), as applicable.
o Provide support to Central HUB for local RRA, as applicable, to ensure all vendor contracts have appropriate PV language incorporated and archived in the global system, as applicable.
o Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs (PSPs) to ensure appropriate safety reporting to GMS or appropriate case management center and HA, as required.
4.
Local Medical Safety Management Benefit Risk Management o Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical Affairs and Marketing organization in collaboration with the International Medical Safety leader.
o Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate.
o Provide Risk Management Plan (RMP) status updates.
o Prepare local RMPs/Addendums, etc.
as applicable.
o Involvement in implementation of RMPs and Urgent Safety Restrictions (USR), if required.
o Participate in meetings with relevant stakeholders for discussion and evaluation of topics related to benefit risk and product safety.
o Involvement in local safety signal detection, if applicable.
o Take appropriate measures to ensure that new safety information is available to HA and Healthcare Professionals (HCPs) in a timely manner, i.
., Direct Healthcare Professional Communication (DHPC), company core datasheet (CCDS) implementation into local label, USR if applicable.
o Involvement in DHPCs management, submit and track DHPCs to HAs/HCPs, as applicable.
o Support to implement CCDS into local label, when required.
o Provide input into safety sections of local protocols (including Clinical Trials, Non-Interventional Studies, RRAs, PSPs etc.) to ensure appropriate safety reporting as required by regulations.
o Perform concept and protocol review related to data generation activities - clinical and post-authorization studies (for Pharma in RECAP) and local Safety Monitoring Plan (SMP).
o Medical safety review of individual cases from global safety database when requested.
o Provide medical input and insights for aggregate reports.
Local Medical Safety training support o Perform PV training for LOC employees covering (pharmacological) safety aspects of products and follow-up process for concepts of special interest (Watchlist).
5.
Collaboration & Support Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local HA to the appropriate global and regional groups (GMS Support Desk, GMS Physician, QPPV Office, VP PV & Medical Compliance) as appropriate.
Collaborate with appropriate departments to identify the resources and expertise needed to address the question.
This may include local, regional and/or global expertise.
Support the Qualified Person (QP) to provide safety-related regulatory communication (e.
., response to request for information from local HA, including the provision of information about the volume of sales or prescription, as appropriate), as applicable.
Has free access to the QPPV to raise any compliance or safety issues independently of the reporting lines.
Participate in the Product Issue Management teams, as appropriate.
Provide technical and strategic input and participate in projects led by the regional GMS team and GMS work streams.
Provide timely and accurate PSMF contribution.
Ensure adequate process is established for the implementation and the maintenance of the local “PSMF” as applicable.
6.
Procedural Document Ensure implementation of Global PV relevant Procedural Documents as applicable and/or write, validate, and implement the Local Implementation Documents (LID) for Regional / IPV Standard Operating Procedures (SOPs)/Working Practices and verify adherence.
Where appropriate develop local controlled procedures to cover local aspects of PV activities.
Ensure all local PV quality documents are reviewed and updated as applicable at minimum every 3 years.
Ensure all required documents related to PV departmental activities are retained according to SOPs and regulatory requirements.
7.
Training Maintain a version-controlled training matrix/plan for local PV personnel which includes, but is not limited to, local SOPs, local regulations and references to the global affiliate PV courses allocated in Learning Management System (e.
.
SUMMIT).
Perform PV training to maintain awareness of drug safety reporting in general for LOC employees, as required; and ensure proper documented training.
Manage AE/PQC training to distributors/vendors and translation of AE/PQC training material, where needed.
Support global roll out AE/PQC training in LOC.
Ensure compliance with local PV training requirements and mandatory training as required by GMO.
8.
PV contract management Management of local PVAs and ensure local implementation, including LSU training and adherence to PVAs.
Function as IPV Lead reviewer, to have PVA implementation and oversight.
Coordinate the provision of support for third party safety agreements locally e.
., local Vendor Agreements as necessary, seek support from central functions like PV Service and Technical Contracts Group and Central HUB, as necessary.
Reconcile local PV agreements with the PV agreements database e.
., International Contracts Database (ICD) and complete an attestation documenting this review in the PV agreements database, in a timely manner.
Maintain and update inventory of all PV relevant agreements signed by LOC, including but not limited to commercial agreements, service, and technical agreements, within the PSMF, including status and list of applicable products.
Take responsibility for POLO agreements, and support the implementation of the PV agreement locally, as appropriate.
9.
Safety Policy and Strategy PV regulations monitoring & implementation Ensure awareness of changes in regulations which may have an impact on PV activities and responsibilities and report regulatory requirements for MAH and/or study sponsor as applicable as per process.
Review and evaluation of the impact of new/revised PV regulations on local processes and notification of appropriate global and regional groups via central PV policy tracker about changes in local regulatory safety including medical device safety reporting requirements.
Implementation of new legislations with local impact for IPV owned activities.
Shaping regulatory environment Focused engagement in local industry associations and drive local policy shaping initiatives based on One J&J Voice.
10.
Audit & inspection readiness Act as the local PV contact person for all PV audits and inspection and coordinate the audit and inspection preparations for internal PV audits e.
., Bioresearch, Quality & Compliance (BRQC) and external PV inspections.
Assist inspectors/auditors, support document requests in collaboration with relevant stakeholders.
Address follow-up actions from findings.
Ensure that any HA communications are forwarded to the required PV personnel and that any responses/corrective actions are tracked and completed according to schedule.
11.
Business Continuity Ensure that a process is in place for reporting of AEs after hours, and testing is documented as per Global and Regional requirements.
In collaboration with Case Management team, ensure that a disaster recovery/business continuity plan (BCP) is established in a risk-based manner to allow for continuation of critical business processes for PV, e.
., inspection readiness, AE reporting coverage etc.
Ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained at the LOC level.
Qualifications Essential Knowledge & Skills Sound knowledge of general medicine or pharmacy and clinical practice, scientific/life-science background, medicinal knowledge preferred; proficiency in medical terminology (local languages).
Proven ability to organize workflow activities and manage 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 skills, fluency in local language(s) and English language required.
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.