Senior Pharmacovigilance Specialist

7 months ago

Johannesburg, South Africa Abbott Laboratories Full time

**About Abbott**

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

**Working at Abbott**

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

- Career development with an international company where you can grow the career you dream of.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

**The Opportunity**

This position works out of our Roodepoort Offices, Abbott Place in the Established Pharmaceutical Division where we are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

The role of Pharmacoviligence Specialist ensures that all activities related to pharmacovigilance (PV) for both Abbott EPD investigational and registered medicinal products are performed at Affiliate level in accordance with internal Abbott policies and procedures as well as with local regulatory requirement.

**What You’ll Do**:

- Acts as a local QPPV on a 24/7/365 basis in EAC Affiliate.
- Maintenance of the Affiliate PV System Country Chapter and additional local PV procedures, forms, and templates
- PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance
- Receipt, recording, and reconciliation of safety information
- Safety surveillance including literature and health authority website screening and preparation of local periodic safety reports and Risk Management Plans
- Regulatory submission of safety information
- Basic PV training of local EPD staff
- PV record retention and archiving
- Implementation of out-of-office coverage for receiving and recording safety-relevant information
- Maintenance of local PV product list
- Ensure PV matters in local interventional studies and local non-interventional organized data collection schemes.
- Negotiation and implementation of local commercial pharmacovigilance agreements and local pharmacovigilance service agreements
- Due Diligence for product acquisition or in-licensing negotiated by an Affiliate organization.
- Provision of local PV Compliance metrics and management of non-compliances
- Coordination/management of PV audits and inspections at the Affiliate level
- Ensure vigilance compliant to local legislation for Abbott EPD products beyond medicinal products such as medical devices and food supplements.
- Contribution to benefit-risk assessment of the Abbott EPD products portfolio;
- Act as the key expert for any PV-relevant topics and ensures proactive communication as appropriate;
- Leading regional PV projects and contribution to global PV projects.

**Required Qualifications**
- Pharmacy or related health science degree

**Preferred Qualifications**
- At a minimum 4 years PV experience in pharmaceutical industry or PH Health authority..
- Profound understanding of local PV regulation
- Ability to give attention to the detail.
- Computer literacy (Windows, MS Office)
- Good English language skills
- Good communication skills with internal and external stakeholders
- Excellent time management, organizational and planning skills.
- The ability to work independently and as a part of a team.
- Independent thinker with the ability to challenge the status quo with outstanding interpersonal skills.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

  • Pharmacovigilance Specialist

    24 hours ago

    Johannesburg, Gauteng, South Africa Curiska Full time

    Job Title: Pharmacovigilance SpecialistAbout Us: Curiska is a leading healthcare organization in Southern and East Africa, seeking an experienced Pharmacovigilance Specialist to join our team.Salary: $80,000 - $110,000 per annum, depending on experience.Job Description:We are looking for a skilled professional to oversee product safety and regulatory...

  • Pharmacovigilance Specialist

    2 months ago

    Johannesburg, Gauteng, South Africa Curiska Full time

    Job Title:Pharmacovigilance PharmacistAbout the Role:Curiska is seeking a skilled Pharmacovigilance Pharmacist to oversee product safety and regulatory compliance across Southern and East Africa. The ideal candidate will maintain quality systems, train staff, and manage safety data with a focus on adherence to GxP, ICH, and pharmacovigilance guidelines.Key...

  • Pharmacovigilance Specialist

    24 hours ago

    Johannesburg, Gauteng, South Africa Curiska Full time

    About CuriskaWe are a leading company in the field of pharmacovigilance, dedicated to ensuring the highest standards of product safety and regulatory compliance across Southern and East Africa.Job SummaryWe are seeking an experienced Pharmacovigilance Pharmacist to oversee product safety and regulatory compliance across our region. The ideal candidate will...

  • Pharmacovigilance Specialist

    2 months ago

    Johannesburg, Gauteng, South Africa Curiska (Pty) Ltd Full time

    Job Title: Pharmacovigilance PharmacistOverview: Curiska (Pty) Ltd is seeking a skilled Pharmacovigilance Pharmacist to oversee product safety and regulatory compliance across Southern and East Africa.Key Responsibilities:Quality Management: Ensure adherence to GxP, ICH, and pharmacovigilance guidelines. Train staff on SOPs, provide SOPs during audits,...

  • Pharmacovigilance Specialist

    3 weeks ago

    Johannesburg, Gauteng, South Africa Aspen Pharma Group Full time

    Job Title: Pharmacovigilance Specialist - Regulatory AffairsAbout the Role:In this exciting opportunity, you will play a crucial role in ensuring the compliance of Aspen Pharma Group with regulatory requirements for pharmacovigilance across the South African and SADC regions. As a Pharmacovigilance Specialist - Regulatory Affairs, you will be responsible for...

  • Safety and Compliance Specialist

    1 month ago

    Johannesburg, Gauteng, South Africa Curiska (Pty) Ltd Full time

    OverviewWe are seeking a highly skilled Safety and Compliance Specialist to oversee product safety and regulatory compliance across Southern and East Africa.Key Responsibilities:Quality Management: Ensure adherence to GxP, ICH, and pharmacovigilance guidelines. Develop and implement quality systems, provide training to staff, report Adverse Drug Reactions...

  • Regulatory & Quality Control Specialist

    6 months ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 70885 **Job Type** - Permanent **Job Title** - Regulatory & Quality Control Specialist **Computer Skills** - Intermediate to Advanced MS Word, Excel, PowerPoint **Industry** - Pharmaceutical **City** - Johannesburg **Province** - Gauteng - This person will also be the Deputy Responsible Pharmacist of the Company.**Summary of...

  • Senior Regulatory Affairs Pharmacist

    7 months ago

    Johannesburg, South Africa Six Sense Full time

    Gauteng, JHB - Eastern Suburbs - Annually Cost To Company (Market related) Well established pharmacuetical business seeking to appoint Senior Regulatory Affairs Pharmacist. **SKILLS & QUALIFICATIONS**: - Bachelor’s degree in Pharmacy, registered with the South African Pharmacy Council - MSc, MBA or PhD may be an advantage. - Experience in regulatory...

  • Regulatory Affairs Manager Position

    24 hours ago

    Johannesburg, Gauteng, South Africa Curiska Full time

    Curiska is seeking a Senior Regulatory Affairs Manager to oversee product registration and dossier maintenance in the SEA Cluster.The estimated salary for this position is R1,200,000 - R1,800,000 per annum, depending on experience.We are looking for a detail-oriented individual with at least 10 years of experience in Regulatory Affairs, specifically in human...

  • Regulatory Compliance Specialist

    4 weeks ago

    Johannesburg, Gauteng, South Africa ES Recruitment Full time

    Are you a skilled professional seeking a challenging role in regulatory compliance for the pharmaceutical industry? We are looking for an experienced Regulatory Compliance Specialist to join our team at ES Recruitment.Job Summary:We are seeking a highly motivated and detail-oriented individual with expertise in regulatory affairs and pharmaceutical...

  • Senior Cabinet Maker and Furniture Craftsman

    1 month ago

    Johannesburg, Gauteng, South Africa Zeebra Junction Specialist Recruitment Full time

    Company OverviewZeebra Junction Specialist Recruitment is a leading recruitment agency in Johannesburg, specializing in placing top talent with the most sought-after companies.Salary:We offer a competitive market-related salary of R250,000 per annum to our successful candidate, reflecting their skills and experience.Job DescriptionThe ideal candidate will be...

  • Senior Clinical Pharmacist Manager

    4 weeks ago

    Johannesburg, Gauteng, South Africa MSP Staffing LTD Full time

    Company OverviewMSP Staffing LTD is a leading healthcare facility in Johannesburg that provides high-quality pharmacy services to patients.Salary and BenefitsThe salary for this position is R750,000 - R900,000 per annum, depending on experience. In addition to the competitive salary, we offer a range of benefits, including health insurance, retirement plan,...

  • Senior Courier Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Road Accident Fund Full time

    Job Title: Senior Courier SpecialistWe are seeking a skilled and experienced Senior Courier Specialist to join our team at the Road Accident Fund in Gauteng. As a key member of our operations team, you will be responsible for ensuring the timely and secure delivery of documents and packages to various locations.

  • Regulatory Compliance Specialist

    2 months ago

    Johannesburg, Gauteng, South Africa ES Recruitment Full time

    Key Responsibilities:The successful candidate will be responsible for ensuring regulatory compliance with Act 101 and Act 53.Act as Responsible Pharmacist for the entity.Develop and implement regulatory strategies and plans.Prepare and submit dossiers for regulatory approval.Manage quality and compliance with a focus on quality management system and...

  • Government Affairs Senior Specialist South Africa

    6 months ago

    Johannesburg, South Africa Organon Full time

    **The Position** The Government Affairs Senior Specialist will be responsible for developing and implementing policy and government affairs objectives in a wide range of priorities, healthcare reform, pricing and reimbursement, trade and intellectual property protection and therapeutic area policy. The position will be an integral part of the Government...

  • Senior Sales and Customer Service Specialist

    1 month ago

    Johannesburg, Gauteng, South Africa MPRTC Full time

    Job Title: Senior Sales and Customer Service SpecialistWe are seeking a highly experienced and skilled Senior Sales and Customer Service Specialist to join our team at MPRTC.

  • Senior Specialist

    6 months ago

    Johannesburg, South Africa Mass Staffing Projects Full time

    **Job Information** - Location- Johannesburg- Salary- R1,2mil - R800k- Job Type- Permanent- Education- CA(SA)- Experience- 4-6 years post-articles experience, Management experience in a banking environment- Reference- SS13092021SW- - finance.jobs(at)staffingprojects.co.za- Fax- 0865728847Job Title: Senior Specialist Location: Johannesburg **Salary**:...

  • Senior Administrative Specialist

    1 month ago

    Johannesburg, Gauteng, South Africa Elixirr Partners LLP Full time

    OverviewElixirr Partners LLP is a dynamic consulting firm seeking a highly skilled and organized Senior Administrative Specialist to support our day-to-day operations.

  • Senior Accounting Specialist

    1 month ago

    Johannesburg, Gauteng, South Africa EMPIRE RECRUITMENT Full time

    Senior Accounting SpecialistWe are seeking an experienced Senior Accounting Specialist to join our team at Empire Recruitment. The ideal candidate will have a strong background in accounting and finance, with a focus on ERP systems.Key ResponsibilitiesManage ERP software enhancements and updatesInduct new employees on ERP softwareCreate manuals on new ERP...

  • Senior Taxation Specialist

    4 days ago

    Johannesburg, Gauteng, South Africa Network Recruitment Full time

    Job Title: Senior Taxation SpecialistAbout the Role:Network Recruitment is seeking a highly skilled Senior Taxation Specialist to join their team. This is an excellent opportunity for a professional with strong taxation experience to contribute to the success of a leading healthcare entity.Key Responsibilities:Tax planning and reportingDealing with SARS and...