PV Compliance Specialist
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Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
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/AIn 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)
Required Experience:
IC
Key Skills
- Abinitio
- Apprentice
- Dermatology
- Cost Estimation
- Data Networking
- Liaison
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
