Pharmacist / Pharmacovigilance Specialist at HRLeverage Africa

Job Description

• The position holder will report to the Pharmacovigilance Manager, Middle Africa. The person would also be responsible for Pharmacovigilance activities in compliance with local and company requirements across Middle Africa (49 countries).
• You will also act as an affiliate safety reporting person. Besides you will be ensuring timely review, update, and reporting of all cases of Customer complaints and Adverse Reactions.

Product safety surveillance:

• Contribute to pharmacovigilance processes ensuring total compliance with industry regulations and legislations for the countries in Middle Africa
• Having oversight of the pharmacovigilance system in Middle Africa countries including quality management system.
• Preparing, reviewing, and implementing company SOPs for PV activities in Middle Africa countries
• Handling of all local drug safety information, including collection, registration, and transmission to Global Safety in a timely manner
• Performing screening of relevant local medical/scientific literature in accordance with Global Safety procedures and local requirements
• Performing screening of relevant local health authority web sites
• Collaboration with medical affairs, quality assurance, regulatory affairs, marketing, and sales to ensure safety reporting procedures are in place, safety relevant information is processed in a timely manner, and reconciliation is completed.

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

Training activities:

• Completion of all mandatory PV trainings in a timely manner
• Supporting PV training activities under the supervision of the Pharmacovigilance Manager
• Supporting the Pharmacovigilance Manage Pharmacovigilance Manager in PV related trainings as required

Act as the Nigeria Qualified person for pharmacovigilance:

• Acting as the single point of contact for any HA inquiries on all matters relating to Pharmacovigilance
• Serve as a point of contact during Pharmacovigilance Inspections
• 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 Nigeria Specific Risk Management Plan annex) when requested by the Authority. Signing declaration accompanying all RMPs submitted to HA.
• All other roles and responsibilities as stated in the Nigeria Good Pharmacovigilance guidelines.

Candidate Qualifications

• You must hold a Bachelor's Degree in Pharmacy.
• 2- 5 years of experience working as a Pharmacist.
• Previous experience as a pharmacovigilance in Middle Africa is an added advantage

Other skills and competencies:

• Strong intercultural skills
• Strong team-working skills -working across cultural and functional boundaries, and participating in “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
• You are good at computer and IT skills and a working knowledge of systems.

Salary

• Annual gross - N4 million - N5 million + other benefits