Senior Pharmacovigilance Specialist

4 weeks 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.

  • Senior Pharmacovigilance Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Abbott Laboratories Full time

    About AbbottAbbott 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 AbbottAt 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...

  • Senior Pv Specialist

    3 weeks ago

    Johannesburg, South Africa Six Sense Full time

    Gauteng, JHB - Eastern Suburbs - Annually Cost To Company (Market related) Well established pharmaceutical business seeking to appoint a Senior PV Specialist (Affiliate) Responsible for the managing, maintenance and continuous improvement of the Pharmacovigilance (PV) system. **Minimum Requirements**: - Medical, Pharmacy or Life-sciences Degree...

  • Senior Pv Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Six Sense Full time

    Gauteng, JHB - Eastern Suburbs Annually Cost To Company (Market related)Well established pharmaceutical business seeking to appoint a Senior PV Specialist (Affiliate)Responsible for the managing, maintenance and continuous improvement of the Pharmacovigilance (PV) system.Minimum Requirements: Medical, Pharmacy or Lifesciences Degree (Bachelor's or Master's)...

  • Senior Patient Safety Associate

    2 weeks ago

    Johannesburg, Gauteng, South Africa AstraZeneca Full time

    Do you have expertise in, and passion for science working in Patient Safety field? If so, AstraZeneca might be the one for you_ABOUT ASTRAZENECAAstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious disease. But we're...

  • Regulatory & Quality Control Specialist

    3 weeks 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 Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa MTN Full time

    Context (Global influences, environmental / industry demands, organizational mission etc.)MTN is entering a new phase in its lifecycle where operational and commercial excellence has become critical for success. The urgency for change has become more heightened amidst increased competitive intensity across all markets in which MTN operates.The Senior...

  • Senior Regulatory Affairs Pharmacist

    4 weeks 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...

  • Senior Property Underwriter

    3 weeks ago

    Johannesburg, South Africa F & G Sourcing Specialist Full time

    Our Short-term Insurance client is seeking a **Senior Property Underwriter** to join their team in Johannesburg. **Salary**: R1mil - R1.2mil p/a **Requirements**: - Bachelor’s degree or relevant insurance related diploma: AIISA or FIISA or similar - Recommendation: Management or Leadership qualification - Must be able to demonstrate property...

  • Senior Recruitment Specialist

    4 weeks ago

    Johannesburg, South Africa Edge Executive Search Full time

    Senior Recruitment Specialist - 2023-08-25 - 2023-09-24 - Permanent - JHB003070 - Human Resources- Gauteng, JHB - Central - Neg - Neg Monthly Basic Plus Commission (Market related, Negotiable)- Our client, a dynamic, fast-growing specialist consulting company in JHB North, requires a Senior Headhunter & Recruitment Specialist. Join an award-winning company...

  • Senior Regulatory affairs pharmacist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Curiska Full time

    JOB TITLE: Regulatory Affairs PharmacistCOMPANY: Pharmaceutical CompanyDESCRIPTION: Join our team as a Regulatory Affairs Pharmacist to ensure a smooth product registration process and compliance with all regulations. Your role involves overseeing regulatory documentation, managing safety updates, and maintaining pharmacovigilance requirements.DUTIES AND...

  • Commercial Quality Senior Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Johnson & Johnson Full time

    "Caring for the worldone person at a time" inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people...

  • Senior Specialist

    3 weeks 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 Regulatory affairs pharmacist

    4 weeks ago

    Johannesburg, South Africa Curiska Full time

    JOB OVERVIEW: Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain comapanys pharmacovigilance requirements. DUTIES AND RESPONSIBILITIES: • Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist• Ensure and supervise that...

  • Senior Regulatory affairs pharmacist

    4 weeks ago

    Johannesburg, South Africa Curiska (Pty) Ltd Full time

    JOB OVERVIEW:Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain comapanys pharmacovigilance requirements.DUTIES AND RESPONSIBILITIES:• Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist• Ensure and supervise that...

  • Senior Regulatory affairs pharmacist

    4 weeks ago

    Johannesburg, South Africa Curiska Full time

    JOB OVERVIEW:Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain comapanys pharmacovigilance requirements.DUTIES AND RESPONSIBILITIES:• Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist• Ensure and supervise that...

  • Government Affairs Senior Specialist South Africa

    3 weeks 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 IT Architecture Specialist

    3 months ago

    Johannesburg, South Africa Immploy Recruitment Full time

    SUMMARY OF ROLE The Senior IT Architecture Specialist will be responsible for leading and coordinating Infrastructure andbusiness projects from a technology architecture perspective, conceptualising architectural approaches,developing and validating both on premise and cloud architecture and high level solution design againstbusiness requirements and best...

  • Senior Regulatory Affairs Pharmacist

    2 weeks ago

    Johannesburg, Gauteng, 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 affairs, preferably in...

  • Senior License Specialist

    3 weeks ago

    Johannesburg, South Africa Dimension Data Full time

    Are you looking for a job that allows you to make an impact on people's lives? Do you want to work long hours, with little flexibility but with great benefits? Are you looking for a job where your opinions count and you can make an impact? We think this Senior License Specialist was created for you! Please read through and apply. As a Senior License...

  • Senior Sustainability Specialist

    2 weeks ago

    Johannesburg, South Africa Six Sense Full time

    Gauteng, Johannesburg - Annually Cost To Company (Market related) A well-established company is seeking to appoint Senior Sustainability Specialist. **Qualification**: - Matric / Grade 12 / National Senior Certificate - Advanced Diplomas/National 1st Degrees - Minimum 3-year relevant natural science or engineering degree. **Experience**: - Minimum...