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Purpose of the role
To ensure compliance with Pharmacovigilance requirements and manage safety evaluations of products within South Africa and SADC region.
Key Responsibilities
- Manage Pharmacovigilance activities for new product launches and existing portfolio in South Africa and SADC region.
- Lead and oversee aggregate safety reporting and signal detection activities.
- Act as Subject Matter Expert (SME) in Pharmacovigilance, ensuring adherence to regulatory requirements and internal SOPs.
- Collaborate with Regulatory Authorities and Contractual Partners on safety-related issues and submissions.
- Lead and mentor Pharmacovigilance team members, ensuring high-quality deliverables and compliance with PV standards.
- Develop and implement Risk Management Plans and oversee safety communication activities.
Minimum Qualifications & Experience
- Bachelor of Pharmacy Degree or equivalent.
- Documented experience in all aspects of Pharmacovigilance.
- 3-5 years of pharmaceutical industry experience with a focus on PV/Drug Safety.
- Proficiency in working with safety databases and conducting safety data analyses.
- Experience in writing large safety reports such as DSURs, PADERs, PSURs, PBRERs.
- Familiarity with MedDRA coding dictionary and RMP writing preferred.
Competencies (Skills, Behaviour & Knowledge)
- Results-driven with a focus on exceeding expectations.
- Strong integrity and work ethic with the ability to meet deadlines.
- Excellent interpersonal and communication skills.
- Proactive problem-solver with a positive and adaptable approach.
Application Process
Medi Careers Specialist Recruiters is a division of Think-Career group and a proud member of the Federation of African Professional Staffing Organizations (APSO). You will now be redirected to https://www.thinkcareerrpo.com/ for a secure application process should you be interested to apply or register to be added to our talent community.
Disclaimer
Think-Career Group is dedicated to fostering diversity and inclusion in the workforce. We encourage applications from candidates of all backgrounds, experiences, and abilities who meet the minimum requirements of the job advertised. Our commitment to diversity extends to our clients, and we work diligently to connect talented individuals with opportunities that promote equality and inclusivity. We strive to ensure that every candidate receives fair consideration, free from discrimination or bias.
More Information
- Address South Africa
- Experience Level Middle Manager
- Total Years Experience 5
- Academic Qualification bachelor-degree
