LOCAL SAFETY SPECIALIST
JHB
Pharmaceutical Sector – Consumer Health

Leading Pharmaceutical Company seeks a suitably qualified / experienced Local Safety Specialist to join their dynamic team.

Purpose of position
• Primary responsibility for supporting the coordination of safety reporting requirements as required for Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.
• Responsible for the collection, review and reporting of Adverse Events (AEs), AEs combined with Product Quality Complaints (AEs + PQCs) and pregnancy reports obtained through the following sources: spontaneous, solicited, clinical studies, date generating activities, Local Regulatory Authorities (RAs) and other potential sources e.g. Literature sources.
• Supporting the Local Safety Officer to ensure and appropriate PV system is continuously maintained.

MINIMUM REQUIREMENTS:
• B.Pharm Degree and / or equivalent medical expertise and experience in Pharmaceutical regulations

Experience:

• Sound knowledge of general medicine, pharmacy and/or clinical practice.
• Pharmacovigilance experience will be an advantage.

Special Requirements:

• Attention to detail and strong methodical preference
• Effective in working as a team, or as an individual
• Ability to communicate effectively with a broad range of stakeholders, verbal and written communication skills
• Computer literate with knowledge of relevant IT systems