ProductLife Group is looking for an Associate Manager Pharmacovigilance to join our hub to oversee and work closely with our PV team to ensure compliance with regulatory standards and accurate safety data.
Responsibilities:
Team and client management:
- Key trainer and manager for junior team members to increase quality and expand knowledge of PV activities including case processing
- Review and identify areas of improvement
- Provide expertise and act as SME for the team, ensuring understanding of tasks by case management team
- Manage larger client projects and act as a point of contact for the client in the territory
- Monitor client KPI
- Support in the resolution of NC/CAPA, identify RCA and implement improvements
- Perform Quality Control/Medical Review and provide support to the team where necessary to ensure regulatory compliance
- Participate in audits and inspections as required
- Ensure understanding of client needs and ensure expectations are met and exceede
- Organise team meetings as requested
Patient safety and risk management:
- To perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients, in accordance with agreed timelines, as required
- Management of the generic or client specific email boxes as appropriate.
- Registration, triage, assignment and coordination for the processing of vigilance cases
- Follow-up requests with local reporters
- Responding to queries from client and reporters
- To carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG Clients
- Support/Contribute to local pharmacovigilance (PV) activities performed by the Local safety/PV department as needed
- To participate in audits / inspections and resulting action plans
Education and Experience:
- HCP – Bachelor’s or Master’s degrees (according to the country and the experience) in Medicine, Pharmacy, nursing, midwifery etc.
- 4+ years’ experience in pharmacovigilance
- Previous experience working to deadlines
- Client interactions, meetings and communication
- Minimum 2 years’ experience working for service providers performing data entry and QC of cases
- Knowledge of US FDA PV regulations
- Team management
- Mentoring Junior members of staff
Skills:
- Good understanding of MS Word, MS Excel
- Pharmaceutical background – strong understanding of GCP, FDA and regulatory requirements related to drug safety.
- Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment
- Excellent organizational and interpersonal skills
- Ability to work well within a team
- Excellent time management skills
- Accountability and autonomy with assigned tasks
- Process orientated with good attention to detail
- Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.
- Flexibility and adaptability to handle a dynamic workload
- Works well under pressure and working to timelines
- Safety database experience