JOB DESCRIPTION:

Primary Job Function:

• To provide support in the establishment, maintenance and development of the PV compliance monitoring system.
• Review and data entry of metrics in compliance tracking systems and tools.
• Metric collection and preparation of the regular management reports

Core Job Responsibilities:

• Collection of compliance data within GPV and other stakeholders of the PV- and medical device vigilance system within the agreed timelines.

• Maintains and further develops the compliance monitoring system and compliance tracking databases with the support of IT.

• Collates metrics and drafts compliance overviews (Key Performance Indicators (KPls), PV Compliance Summaries).

• Requests non-compliance information I corrective/preventive actions when not provided by the non-compliant party.

• Performs regular CAPA reviews and follow-up with responsible organization in case of quality issues

• Manages the tracking of non-compliance information/ corrective/preventive actions and generates periodic reviews of compliance data and trending of root causes.

• Initiates investigations of non-compliance occurrences and documents investigation findings and proposes solutions according to the process defined within GPV.

• Assists in the liaison with relevant interfaces to ensure compliance is monitored for GPV through relevant KPls.

• Participates in training of relevant personnel on Compliance relevant topics (e.g. Affiliate tracking of submissions, CAPA Management Tool).

• Escalates to the Head PV System & Compliance, and if applicable the QPPV, any serious compliance or performance issues in order

to take immediate action (corrective - or preventative action).

The base pay for this position is

N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Product Development

DIVISION:

EPD Established Pharma:

LOCATION:

India > Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)