Pharmacovigilance Compliance Specialist

PV Compliance Specialist

     

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)

     

     

     

Experience Level

Senior Level