Pharmacovigilance Submission Compliance Manager

Main responsibilities:

• Investigation of late case submissions to HA and BP, co-ordination and follow-up with relevant stakeholders for RCA initiation and completion.

• • Generate listing from the Compliance Tracker to identify all late HA submissions.

  • Initiate investigation to identify lateness reason and responsible organization.

  • Liaise with the PV Coordination and check & control Managers to manage batch situations (one situation impacting higher volume of late submissions with same scenario).

  • Follow up with responsible organization to request lateness reason and CAPA.

  • Validate the information upon receipt of lateness reason and CAPA and follow up as needed.

  • Complete data entry in the Compliance Tracker with lateness reason and CAPA information. The data entry should be accurate as agreed and validated.

  • Generate listing in the Compliance Tracker of all CAPA due and/or overdue and follow up with CAPA owner on status.

  • Attend ICSR compliance meetings to support with discussion of late ICSR to Main Health Authorities. Maintain tracker/oversight of responses and follow up as needed

• Investigations of late distribution of ICSRs to Business partners

• • Manage Business Partner complaints.

  • Generate listings from Compliance Tracker for late distributions to tracked partners

  • Monitor complaints from Business partners in relation to late distribution of ICSRs and initiate investigation upon receipt of complaint.

  • Initiate investigation for lateness distribution.

  • Follow up with responsible organization to request lateness reason and CAPA.

  • Validate the information upon receipt of lateness reason and CAPA and follow up as needed.

  • Complete data entry in the Compliance Tracker with lateness reason and CAPA information. The data entry should be accurate as agreed and validated.

  • Prepare and send response to Business partner.

  • Maintain a tracking of Business partner complaints.

• Monitoring CAPA till completion, Management of lateness documentation form, identify the Deviation Owner, Follow-up in case of no response,

• Identify potential critical and major systemic deviation and escalate as required.

• Identify Trends during ongoing investigations and as part of retrospective reviews. 

• Participate to the remediation of compliance gaps in collaboration with stakeholders owning the corrective and preventive actions (CAPA).

• Perform KPI, transfer responses into PV database.

• Perform review of late case investigations & data entry of RCA & CAPA

• Coordinate late case investigation findings with stake holders.

• Ensure regular conduct of investigation of late case submissions to HA and BP, co-ordination and follow-up with relevant stakeholders for RCA initiation and completion, investigations of late distribution of ICSRs to Business partners, PSR compliance dashboard quality check

• Manage & provide monthly and quarterly project related metrics

• Manage Monthly, Quarterly, and Semester meetings to provide KPI related to CHC regarding late cases KPI, e.g., main lateness reasons, delay, Deviation Owner, Collection Organization, time to response, number of disagreements, amounts of complaints from BP, PSR compliance, checks of PSR supporting tools

• Present the above KPI in meetings (as needed).

• Identify potential critical and major systemic deviation and escalate as required.

• Identify Trends during ongoing investigations and as part of retrospective reviews. 

• Participate to the remediation of compliance gaps in collaboration with stakeholders owning the corrective and preventive actions (CAPA).

• To perform the reconciliation activities between Compliance Tracker report(s) and LSMV report(s) to identify the inconsistencies in the compliance data at case level for each quarter

• Perform work allocation and management & periodic reconciliation

• Plan and perform training session to newly recruited staff and refresher training as and when needed

• Create standard listings in the Compliance Tracker (BP Listing), which can be Ad-hoc and/or scheduled.

• Produce standard monthly compliance listings for different partners, complete a QC and format the reports as required.

• Perform quarterly quality review of the data fields in the PSR compliance dashboard to check that data is not missing (example PSR due date has passed and no PSR submission date available, PSR submitted late and no lateness reason or CAPA available).

• To perform the reconciliation activities between Compliance Tracker report(s) and LSMV report(s) to identify the inconsistencies in the compliance data at case level for each quarter

About you

Experience:

• Experience in the Pharmaceutical or Biopharmaceutical industry, ideally 5+ years in consumer healthcare pharmaceutical industry.

• Minimum of 5 years of experience in ICH-GxP-related Quality operations and Compliance, of which 3-4 years’ experience in PV, is mandatory.

• Knowledge of international regulations/Guidelines/Good Practices pertaining to the ICH-GxP

• Good depth understanding of Deviation management, Quality Risk Management and Quality systems

• Good knowledge of submission timelines and thereby compliance to US FDA/MHRA/EMA and other health authorities, along with the goof understanding of business partners’ requirements and their submission compliance for inbound and outbound.

• Knowledge about KPI process and deviation management, PSR and reconciliation process

Soft skills:

• Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.

• Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities.

• Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.

• Excellent team-work and interpersonal skills

• Ability to work in cross-functional teams

• Excellent oral and written communication skills

Technical skills:

• Validation tools (database, compliance tools)

• Experience in PV Audits and Inspection Management

• Good depth understanding of Quality Risk Management and Quality systems

Education:

Scientific background: M.Pharm, Pharm D or Master's Degree in Human Health or License Degree in Human Health Sciences