PV Associate-Compliance

PV Associate-Compliance

PV Associate- Compliance is responsible for raising process deviations, review, documentation, monitoring and follow up of process deviations and implementation of CAPA, Audit and Inspection readiness.

Responsibilities

• Act as SME for deviation and CAPA handling activities during audit and regulatory authority inspections, as needed.

• Collate all CAPA from internal QA audit and Health Authority Inspection and maintain in a summary spreadsheet.

• Review the deviations and CAPA for completeness.

• Follow up on open deviations/CAPA with CAPA owners to ensure completion within agreed timelines. This monitoring will require contact with CAPA owners prior to the due date to ensure CAPAs remain on track.

• Liaise with country affiliates as necessary to receive updates on progress of CAPA for local process deviations and as a result of internal audit/external inspection

• Work closely with the PV Quality & Compliance Lead to ensure oversight of deviations and CAPAs and that summary data is available for presentation at the monthly compliance meeting.

• Ensure deviation and CAPA data is available in a format which can be easily included in the PSMF.

• Ensure that information concerning closed deviations/CAPA are appropriately archived.

• Filing and Archiving: Maintain PV shared folders for safety information, and maintain document security and integrity by filing documents securely on site or sending files to archive.

• Provide data for internal compliance meetings, monthly report and for inclusion in the PSMF as required

• Support for PV QMS: Support the development and revision of department SOPs and work instructions. Also participate in the review of cross-functional SOPs which include reference to PV activities.

• Support during Audit & Inspection by collating and providing PV relevant data.

• Perform other ad hoc, PV related activities as requested by management.

• Relationship Management

• Working within PV team and cross-functionally.

• Interactions with vendor’s/service providers for PV activities.

• Process Improvement / Standardization

• Participate in streamlining Global integration project under supervision of Global Head of PV.

• Desired Skills & Competencies

• Good working knowledge of PV regulations including FDA, EU & local requirements.

• Performs timely coordination of safety information dissemination with minimal direct supervision.

• Excellent teamwork and interpersonal skills.

• Excellent time management and organisational skills.

• Good knowledge of computer applications and software, including MS Word, Excel, PowerPoint etc.

Qualifications

• M. Pharm or equivalent with 2 to 4 years of experience in pharmacovigilance