SEA Patient Safety Center Associate - LQPPV Kenya

Job description

SEA Patient Safety Center Associate - LQPPV Kenya

The PSC Associate is directly accountable for performing all Pharmacovigilance (PV) tasks allocated to the Local Patient Safety organization under the supervision of the PSC Manager in the given Centre’s territory. The tasks must be performed in full compliance with all relevant global and local regulatory requirements and company standards.

 

These include:

 

Product safety surveillance

Handling of all local drug safety information, including collection, registration, translation from local language into English and transmission to GPS as applicable in a timely manner

Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner

Performing screening of relevant local medical/scientific literature in accordance with GPS procedures and local requirements (where applicable)

Performing screening of relevant local health authority web sites according to global standards as defined by relevant quality documents (where applicable)

Collaboration with medical information, quality assurance, complaint management and PDCSs to ensure safety reporting procedures are in place, safety relevant information is processed in a timely manner, and reconciliation is completed

Keeping product knowledge up to date to ensure appropriate Individual Case Safety Report (ICSR) handling

Performing required PV activities in the absence of the PSC Manager

 

Reporting to local Health Authorities and Ethics Committees

Timely submission of expedited ICSRs to concerned local health authorities (where applicable)

Support of e-reporting in e-reporting ready countries (where applicable)

Timely submission of expedited cases to concerned local/central EC/IRBs as applicable

Timely submission of safety issue reports to concerned local health authorities

Timely submission of safety issue reports to concerned local/central EC/IRBs as applicable

 

Compliance related activities

Using applicable tools (e.g. IRT, OST) to ensure local compliance in terms of ICSR handling according to local regulations and company timelines

Supporting the PSC Manager to ensure compliance reports to GPS via the applicable technical tool (e.g. SCCT) in a timely manner

Contributions to the Local PV file in close collaboration with Local PV Responsible (LPVR) persons to support completeness, accuracy and that relevant information is updated in a timely manner

 

Tracking of clinical development and Patient Data Collection Systems (PDCS) activities in the assigned countries

Supporting the PSC Manager that a complete overview on relevant local/ global clinical studies and PDCS (ongoing and planned) in the local affiliates is kept

Supporting the PSC Manager that current global procedures for the handling of PDCS and clinical studies are followed

 

Training activities

Completion of all mandatory PV trainings in a timely manner

Supporting PV training activities under the supervision of the PSC Manager

Supporting the PSC Manager in PV related trainings as required

 

 

The responsibilities of the Local Qualified Person Responsible for Pharmacovigilance in Kenya shall include but not limited to the following:

 

Interacting with Local Health Authority

Acting as first point of contact for any HA inquiries on all matters relating to PV and safety of marketed products including PV inspections

Serve as a point of contact and available during Pharmacovigilance Inspections

Establishing and maintaining a system which ensures that information about all suspected adverse drug reactions/events which are reported to the personnel of the marketing authorization holder (MAH) including to medical representatives, are collected, processed, evaluated and forwarded to the HA in line with the timelines stipulated by the HA.

Preparation and Submission of PV Relevant Documentation to Health Authority:

Adverse Drug Reaction Reports/Individual Case Safety Reports

Periodic Safety Update Reports (PSURs)/Periodic Benefit-Risk Evaluation Reports (PBRER), when necessary

Company-sponsored pre- and post-authorization safety and efficacy study protocols and reports

Risk Management Plans (including Kenya Specific Risk Management Plan annex) when requested by the Authority. Signing declaration accompanying all RMPs submitted to HA.

Ongoing PV evaluation during the post-registration period

 

Communication of Drug Safety Information

Ensure that any request from the Authority or additional information deemed necessary for the evaluation of the risk-benefit ratio of a marketed product, is provided to the Authority promptly and fully

Oversee the safety profiles of the company’s marketed products and any emerging safety concerns.

 

Local Pharmacovigilance (PV) System

Ensuring that the Local PV system fulfils requirements for:

Expedited Reporting and Periodic Safety Update Reporting

Handling of Urgent Safety Restrictions and Safety Variations

Continuous Monitoring of the Safety Profile of the Authorized Medicinal Product

Notifying Competent Authorities and Health Professionals of Changes to the Risk-Benefit Profile of Products

Meeting Commitments made at the time of authorization

Internal audit of the PV system

 

Candidate qualifications:

Required professional experience and necessary training

·  University degree in Health / Life sciences or equivalent background
·  The qualified person for pharmacovigilance (QPPV) shall have minimum requirement of a Bachelor’s Degree in Pharmacy, with additional certificate/diploma/fellowship or post graduate training in good pharmacovigilance practices (GVP) from institutions recognized by Pharmacy and Poisons Board.
·  Excellent skills in written and spoken English
·  Additional foreign languages skills desirable

Necessary professional experience

·  Experience in the pharmaceutical industry or health authority
·  Good knowledge of local regulatory PV legislation
·  Good understanding of drug development and life-cycle management

Specifies personal skills and competencies required

·  Strong intercultural skills (developed from practical experience)
·  Strong team-working skills -working across cultural and functional boundaries, and participating “virtual teams”
·  Good problem-solving and decision-making ability
·  Good organizational skills, ability to prioritize work and adapt rapidly to changing priorities
·  Ability to manage multiple situations/issues under time pressure
·  Effective presentation and training skills

Job Requisition ID: 206871

Location: Nairobi

Career Level: B - Recent University Graduate(

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