Drug Safety Officer

2 weeks ago

Johannesburg, Gauteng, South Africa Cipla Full time

Job Purpose:


Assisting the Drug Safety Manager in ensuring that the Company is at all times, compliant with the relevant laws, regulations and guidelines that govern drug safety and for establishing and maintaining the drug safety system so that information regarding all suspected adverse reactions reported to Company employees, are collected and collated in order to be accessible to get an overall view.

In the absence of the Drug Safety Manager, assume the responsibilities of the DSM as the Deputy.

Key Accountabilities:

1.
Pharmacovigilance PV):

  • Understand various functions of PV and operational aspects.
  • Assist with daytoday PV operational activities.
  • Understand ICSRs (Individual Case Safety Reports) management and assessment as per internal procedures.
  • Act as case owner for assigned ICSRs to ensure accurate completion of data entry (DE), data review (DR) and regulatory reporting (RR), in line with company SOPs.
  • Always to ensure the maintenance of a high standard of case quality processing.
  • Assist in conducting reconciliation of all adverse event reports received by PV from internal and external stakeholders (QA/MI and ACC).
  • Support the preparation of PV SOPs.
  • Assist in closing out all CAPAs, Deviations and Actions on time as per internal company SOPs.
  • Assist in training of all Cipla employees and distributors/service providers on Pharmacovigilance.
  • Understand SDEA obligations in order to ensure all aspects under agreements are dully executed.
  • Highlighting any safety related issues to the attention of the management team
  • Support the continuous development and improvement of the PV function while upholding Cipla core values.
  • Follow-Up on all AE/ADR related queries received from spontaneous/solicited reports within the timelines specified in company SOPs.

2.

Develops and Manages External Stakeholder Relationships:
Complies with the requirements set out in the PVA/SDEA's

3.

Develops and Manages Stakeholder Relationships:

  • Identifies and develops key relationships with Cipla global
  • Leverage compliance expertise and alignment with Global Drug Safety

4.

General:

  • Responding and assisting to ad hoc business requests
  • Undertaking research on a variety of tasks and project and presenting findings in a confident and professional manner
  • Completion of Performance Reviews

Educational qualifications:

  • Passed and

Completed Tertiary Degree:
Degree or Diploma in Health Sciences

  • 13 years in Pharmacovigilance or Medical Affairs.

Skills:

  • An eye for detail and good organisational skills
  • Good communication (both written and verbal) and interpersonal skills
  • The ability to build and maintain healthy relationships
  • To be able to work your way through a highly structured development process whilst on training
  • To be selfmotivated, and take responsibility for your own development
  • To be a team player
  • To be proactive
  • To be able to multitask
  • Take initiative and lead
  • To maintain a professional image at all times
  • A strong ability to learn
  • Takes initiative and leads.
  • To confidently influence and persuade at all levels.
  • To have an organised and systematic approach to work
  • The ability to think independently and creatively.
  • To be able to make decisions and meet deadlines whilst working in a fastpaced, pressurised environment.
  • Resilience and ability to adapt.
  • Deliver on all tasks and projects timeously.
  • Managing time effectively and prioritizing work to meet required timelines

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