Job description
Reporting to the Regulatory Affairs Manager, the incumbent will be expected to:
- Act as the single contact point for NAFDAC on a 24-hour basis (QPPV).
- Establish, maintain, and manage the pharmacovigilance (PV) system of May & Baker Nigeria Plc. and its subsidiaries.
- Prepare the pharmacovigilance system master file and ensure the PV system is appropriately described in the PV System Master File (PSMF), overseeing its content, maintenance, and ensuring the availability of the PSMF to Competent Authorities (CA).
- Prepare May & Baker for pharmacovigilance audits by regulatory authorities.
- Have an overview of the safety profiles and any emerging safety concerns concerning the medicinal products for which May & Baker Nigeria Plc. has received Marketing Authorization.
- Prepare Periodic Safety Update Reports for products and submit same to relevant Regulatory Authorities.
- Monitor and submit Adverse Drug Reactions to NAFDAC of May & Baker group products.
- Handle suspected faking of May & Baker group products.
- Applicants must possess a B. Pharm, Pharmacology or Biological Sciences Degree and must have completed NYSC