Senior Pharmacovigilance Associate

4 weeks ago

Centurion, South Africa Profession Hub Full time

Our client is searching for a Senior Pharmacovigilance Associate to join their team in Irene Centurion.

**Job Profile**

The Organisation is a rapidly growing global speciality pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely, on time and wherever they are needed in the world. As a Senior PV Associate, you will work within the Pharmacovigilance Operations Team and will be dedicated to one or more of our pharmaceutical clients with a truly global presence supporting the collation, processing and analysis of safety information on behalf of a Client(s) product(s); this unique industry-changing
relationship redefines collaboration. This role requires you to be a passionate pharmacovigilance professional, who is a dedicated and enthusiastic team player, who wants to work with a new business that strives to gain and maintain an exceptional reputation as a PV Service Provider who is knowledgeable, cares and produces high-quality work.

**Key Responsibilities**

**For the Company**
- Working within the Pharmacovigilance Operations Team.
- Assess and process serious adverse events (SAEs) and Individual Case Safety Reports (ICSRs) in the Global Drug Safety database.
- Experience and qualified to perform quality control of other PV Operations activities.
- Support quality and efficiency strategies within the organization.
- Support the Company by attending BID defence meetings.
- Support in the provision of regular updates regarding the status of specific project/ Client activities.
- Developing PV medical training presentations and delivering training, as required.
- Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in the PV inspections or audits.
- Contributes to improvements of team processes.
- Other PV operational activities or initiatives as assigned.
- Maintaining good client relations and ensuring a consistently high quality of work for each client.
- Mentoring and training of new PV staff as relevant.
- Support with relevant SOP authoring, ensure all contractual requirements with regards to Pharmacovigilance are updated in the relevant procedures, and contribute to and ensure system improvement.
- Review Medical Information Enquiries and Product Quality Complaints to ensure all safety information has been captured.
- Provide backup to PV Associates as required

**For the Clients**
- Managing mailboxes - responding to data entry/ case processing queries from Clients and Client Partners, responding.
- Support with QC of safety data management from client Managed Access Programmes.
- Ensure all internal and external queries are tracked/ professionally and efficiently responded to within stipulated timelines.
- Case processing of SAEs and/or ICSRs.
- Case regulatory reporting; preparing relevant cases for submission and sending them to the relevant Regulatory Authorities.
- Working on E2B/R3 format reporting and Case Finalization; reading error messages and taking steps to correct cases as a result of negative acknowledgements.
- Investigating cases of non-compliance of SAEs/ICSRs and supporting the development of non-conformances and corrective and preventative actions.
- Performing Literature Article Reviews.
- Performing follow-ups related to queries and requests regarding case handling.
- Communicating with Clients/ Partners regarding the evaluation and processing of ICSRs.
- Performing quality control of cases in the Global Drug Safety database.
- Expedited Reporting activities involving Work Instruction Updates, System Reporting Rules, Regulatory Intelligence, and Clinical Reporting Instructions Updates.
- Performing reconciliation activities as per Client contracts and each Client Operating Guideline (COG).
- Assists when required in Partner, Health Authority Audits/ Inspections.
- Participation in Client audits and inspections.
- Support the Safety Evaluation and Risk Management (SERM) team with aggregate PV data analysis for signal detection/ aggregate reporting purposes.

**Requirements**:

- Healthcare Professional qualification or the equivalent of a Bachelor of Science (BSc) degree.
- Minimum 2 years’ experience of operating in a similar role is essential. Experience working in the pharmaceutical/healthcare/life sciences industry is advantageous.
- Experience in PV with a demonstrable understanding of PV processes and requirements.
- Evidence of being able to build relationships with key internal and external customers and demonstrate customer focus.
- Attention to detail and the ability to work effectively in an environment characterised by tight timelines and changing priorities.
- Excellent organizational and prioritization skills strong analytical skills and problem-solving skills.
- Excellent oral and written communication skills.
- Experience at working both independe

  • Pharmacovigilance Officer

    1 month ago

    Centurion, South Africa Profession Hub Full time

    Our client, a rapidly growing global specialty pharmaceutical and services company based in Centurion Irene is searching for Pharmacovigilance Officer to join their team. **Requirements**: - Healthcare Professional qualification or equivalent of a Bachelor of Science (BSc) degree. - Proven and demonstrable experience in PV. - Evidence of being able to...

  • Pharmacovigilance Physician

    2 months ago

    Centurion, South Africa Profession Hub Full time

    Our client is searching for a Pharmacovigilance Physician to join their team in Irene Centurion. **Job Profile** This role will play a key role in bringing deep clinical understanding and judgement in benefit-risk assessments for the Organisation and their Client’s products. This role will support the medical components of Pharmacovigilance (PV) for the...

  • Pharmacovigilance Physician

    2 weeks ago

    Centurion, Gauteng, South Africa Profession Hub Full time

    Our client is searching for a Pharmacovigilance Physician to join their team in Irene Centurion.Job ProfileThis role will play a key role in bringing deep clinical understanding and judgement in benefit-risk assessments for the Organisation and their Client's products. This role will support the medical components of Pharmacovigilance (PV) for the...

  • Pharmacovigilance Physician

    3 months ago

    Centurion, South Africa Profession Hub Full time

    Our client is searching for a Pharmacovigilance Physician to join their team in Irene Centurion. Job Profile This role will play a key role in bringing deep clinical understanding and judgement in benefit-risk assessments for the Organisation and their Client’s products. This role will support the medical components of Pharmacovigilance (PV) for the...

  • Pharmacovigilance Physician

    3 months ago

    Centurion, South Africa Profession Hub Full time

    Our client is searching for a Pharmacovigilance Physician to join their team in Irene Centurion. Job Profile This role will play a key role in bringing deep clinical understanding and judgement in benefit-risk assessments for the Organisation and their Client’s products. This role will support the medical components of Pharmacovigilance (PV) for the...

  • Pharmacovigilance Physician

    2 months ago

    Centurion, South Africa Profession Hub Full time

    Our client is searching for a Pharmacovigilance Physician to join their team in Irene Centurion.  Job Profile  This role will play a key role in bringing deep clinical understanding and judgement in benefit-risk assessments for the Organisation and their Client’s products. This role will support the medical components of Pharmacovigilance (PV) for the...

  • Senior Associate

    2 weeks ago

    Centurion, Gauteng, South Africa WNS Global Services Full time

    Company DescriptionWNS (Holdings)Limited (NYSE: WNS) is a global Business Process Management (BPM) leader. WNS offers business value to 400+ global clients by combining operational excellence with deep domain expertise in key industry verticals, including Banking and Financial Services, Consulting and Professional Services, Healthcare, Insurance,...

  • Senior Associate

    2 weeks ago

    Centurion, Gauteng, South Africa WNS Global Services Full time

    Company DescriptionWNS (Holdings)Limited (NYSE: WNS) is a global Business Process Management (BPM) leader. WNS offers business value to 400+ global clients by combining operational excellence with deep domain expertise in key industry verticals, including Banking and Financial Services, Consulting and Professional Services, Healthcare, Insurance,...

  • Associate Director, Regulatory Affairs

    2 weeks ago

    Centurion, South Africa FHI Clinical Inc Full time

    **Essential Functions**: - Expected to be the accountable point of contact for designated clients, responsible not only for RA deliverables but also for proactive communication and budget adherence. - Act as the Lead Regulatory Professional for regulatory projects awarded to FHIC, with support from other senior colleagues. - Provides Clinical Research...

  • Senior Associate

    2 weeks ago

    Centurion, South Africa WNS Global Services Full time

    **Company Description** WNS (Holdings) Limited (NYSE: WNS) is a global Business Process Management (BPM) leader. WNS offers business value to 400+ global clients by combining operational excellence with deep domain expertise in key industry verticals, including Banking and Financial Services, Consulting and Professional Services, Healthcare, Insurance,...

  • Senior Associate

    2 weeks ago

    Centurion, South Africa WNS Global Services Full time

    Company Description **WNS (Holdings) Limited (NYSE**: WNS) is a global Business Process Management (BPM) leader. WNS offers business value to 400+ global clients by combining operational excellence with deep domain expertise in key industry verticals, including Banking and Financial Services, Consulting and Professional Services, Healthcare, Insurance,...

  • Senior Associate

    7 days ago

    Centurion, South Africa WNS Global Services Full time

    Company Description **WNS (Holdings) Limited (NYSE**: WNS) is a global Business Process Management (BPM) leader. WNS offers business value to 400+ global clients by combining operational excellence with deep domain expertise in key industry verticals, including Banking and Financial Services, Consulting and Professional Services, Healthcare, Insurance,...

  • Clinical Operation Manager

    3 weeks ago

    Centurion, South Africa IQVIA Full time

    You will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. The role may also include maintenance activities. This is not a line management position but requires...

  • Clinical Operation Manager

    2 weeks ago

    Centurion, South Africa Novasyte Full time

    You will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. The role may also include maintenance activities. This is not a line management position but requires...

  • Senior Manager IT Audit

    2 months ago

    Centurion, South Africa Six Sense Full time

    Gauteng, Centurion A well-established financial services business is seeking to appoint a Senior Manager IT Audit. Reporting to the Chief Internal Audit Officer, the successful incumbent will lead, manage, and drive IT Audit initiatives including the development of the Internal Audit Methodologies, IT Audit Plan and ensure execution of the plan and any ad...

  • Senior Manager IT Audit

    18 hours ago

    Centurion, South Africa Six Sense Full time

    Gauteng, Centurion A well-established financial services business is seeking to appoint a Senior Manager IT Audit. Reporting to the Chief Internal Audit Officer, the successful incumbent will lead, manage, and drive IT Audit initiatives including the development of the Internal Audit Methodologies, IT Audit Plan and ensure execution of the plan and any ad...

  • Senior Analyst: Strategic Advisory

    6 days ago

    Centurion, South Africa Boardroom Appointments Full time

    **Key purpose**: The Senior Analyst will be responsible for the implementation, execution, and analysis of the Strategic Advisory functions of our company. **Duties and responsibilities**: - Support Mergers and Acquisitions activities associated with acquisitive growth; work with a team to develop pipeline, engage companies, conduct due diligence, and...

  • Senior Manager

    2 weeks ago

    Centurion, Gauteng, South Africa Six Sense Full time

    Gauteng, Centurion Annually Cost To Company (Market related)A well-established financial services business is seeking to appoint a Senior Manager - I.T AuditReporting to the Chief Internal Audit Officer, the successful incumbent will lead, manage, and drive IT Audit initiatives including the development of the InternalAudit Methodologies, IT Audit Plan and...

  • senior electrical engineer

    2 weeks ago

    Centurion, Gauteng, South Africa C3 Resources Full time

    Job title: SENIOR ELECTRICAL ENGINEEREducation Level: B.Eng. (Electrical Engineering) or other applicable qualification. Professional registration.Location: Centurion, South AfricaExperience: Senior Level (+10 years experience)Job Description:Manage staff and costs of the electrical team.Supervise, train and develop staff members as necessary.Develop complex...

  • Senior Architect

    18 hours ago

    Centurion, South Africa AECOM Full time

    **Company Description** Work with Us. Change the World.** At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the...