POSITION TITLE:
Safety Data Management Specialist
DIVISION: Drug Safety
LOCATION: Sandton
REPORTS TO POSITION TITLE: Drug Safety Lead
POSITION SUMMARY
Company Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical
decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you
are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically
necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare
decisions regarding the safe and appropriate use of medicines for patients.
POSITION RESPONSIBILITIES
You will be relied on by the company to monitor its drug, biologics and medical devices surveillance program.
This will include intake, evaluation and processing of the adverse reports received. You will support the clinical
trial as well as the post marketing activities.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team.
Your focus and ability to meet team targets will help in completing important deliverables on time. Your
innovative use of communication tools and techniques will make it easy to manage difficult issues and help in
establishing consensus between teams.
It is your dedication and hard work that will make it possible for Company’s customers and patients to receive the medicines they need, when they need them.
- Contribute to the completion of complex projects, manage own time to meet agreed targets and develop
plans for work activities on own projects within a team. - Provide oversight, team mentoring on case handling aspects, data extraction and analyses and conduct
follow-up activities. - Act as subject matter expert and liaise with key partners regarding safety data collection and data
reconciliation. - Review, analyze, prepare, and complete safety-related reports within scope to determine the safety
profile of Company’s products and to meet regulatory requirements. - Review processed cases to verify accuracy, consistency and compliance with process requirements, and
review case data for special scenarios. - Manage, where applicable, safety resources in the local team.
Provide specific pharmacovigilance or product knowledge and experience, as required by the business,
and mentor colleagues accordingly. - Develop and maintain advanced knowledge of all products within the Company portfolio.
- Develop and maintain expertise of all assigned products, of applicable corporate policies.
- Design and oversee the tracking of applicable safety metrics.
- Manage project and process management meeting established deadlines.
- And search functions in the safety database and data mart.
EDUCATION AND EXPERIENCE - Bachelor’s Degree, life sciences
- At least 12 months pharmacovigilance experience
Page 2
TECHNICAL SKILLS REQUIREMENTS Technical skills required and/or preferred, as applicable. - Demonstrated organizational/project management skills
- Solid knowledge of global regulations and guidelines for drug development
- Demonstrated analytical and statistical skill.
- Ability to make decisions independently and resolve issues appropriately
- Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
- Fluent in spoken and written English
Desired Skills:
- decision making
- analytical
- statistical
- productivity
- organizational
- time management
- excellent communication skills both written and verbal in English
Desired Work Experience:
- 2 to 5 years Pharmaceutical Manufacturing
Desired Qualification Level:
- Degree
About The Employer:
Leading Multi-National Pharmaceutical Industry
Employer & Job Benefits:
- Medical Aid
- Provident Fund
- Car Allowance
- Fuel
- 13th Cheque
- Performance Bonus