Regional Pharmacovigilance Coordinator

**REGIONAL PHARMACOVIGILANCE COORDINATOR**-2206092638W

**Description**

**Johnson & Johnson New Planned Consumer Health Company,** based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.

**Position Summary**

The Regional Pharmacovigilance Coordinator position is responsible for:

- Ensuring that the Local Operating Company (LOC) PV activities, including Individual Case Safety Report (ICSR) case processing related activities, are 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.
- Act as Local Safety Officer & Local PV nominated person for Johnson & Johnson Consumer Health (incl. for cosmetic and device products)

**Key Responsibilities**:
**LOCAL PV RESPONSIBLE**
- Act as local nominated contact for PV (focal point to the Local HA).

**INBOUND & OUTBOUND ICSR CASE MANAGEMENT**
- Daily monitor and review the Mailbox for incoming adverse events, queries, follow-up, and other safety related communication, ensuring responses are provided and actionable items are addressed in a timely manner.
- Support review, identification of ICSR cases at various stages (such as receipt, assessment, and processing of incoming safety information) from multiple sources, both internal and external to the Company.
- Verify and ensure high-quality translation of safety information.
- Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.
- Performing follow-up for requesting additional information from multiple sources (e.g. literature cases, health authorities) and TFUQ.
- Assist in the quality review of data captured in the GIRS/GORS (OST) as applicable.
- Enable mechanisms to support Area Safety Head oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner (e.g. monthly metrics, notification to IPV Affairs).
- Liaise with applicable stakeholder to support case processing requirements for medical device vigilance, or cosmetovigilance as applicable.

**AGGREGATE REPORTING**
- Support timely submission of aggregate safety reports (e.g. line listing, DSUR, PSUR etc. applicable) to applicable health authorities, in collaboration with local medical safety input (as applicable).

**COMPLIANCE MONITORING**
- Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable.

**PROCEDURAL DOCUMENT DESIGN**
- Ensure implementation of PV relevant Procedural Documents as applicable and/or write, validate and implement the Local Implementation Memos (LIM) for Regional / International PV Standard Operating Procedures/Working Practices and verify adherence. Where appropriate develop local controlled procedures to cover local aspects of PV activities.

**SAFETY POLICY/STRATEGY**
- Ensure awareness of changes in regulations which may have an impact on vigilance activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups (i.e. QPPV offices and Regional Area Safety Lead) of any changes to local laws and regulations regarding safety.

**SAFETY TRAINING**
- Ensure proper documented training on drug safety reporting responsibilities of LOC personnel and maintenance of awareness of drug safety reporting in general.

**AUDIT/INSPECTION PREPARATION & SUPPORT**
- Collaborate with the LATAM Area Safety Head to ensure Local Safety Unit audit & inspection readiness at all times.
- Assist inspectors / auditors, support document requests.

**OTHER ACTIVITIES**

Ensure and support other case management related activities such as:

- Local vendor management & training, on-going vendor support on a case level (daily or as required), case review, and vendor oversight (daily or as required).
- Local literature screening for ICSRs and potential safety signals (in consultation with local medical safety as needed).
- Periodic reconciliation activities.
- Support Regional Lead / LSO in responding to ad hoc requests (e.g. regulatory authority requests) as required.
- Support the coordination and process standardization efforts to cross-country collaboration with regards to case management activities, as applicable
- Support project work or other safety/case management-related duties as assigned

**Qualifications**
- Degree qualified in life or health sciences
- Minimum of 6 ye