Drug Safety Officer

4 months ago

Johannesburg, South Africa Cipla Full time

**Division**:
Regulatory Affairs

**Department**:
Medical Affairs

**Employment Type**:
Permanent

**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 Drug Safety Manager as the Deputy Qualified Person for Pharmacovigilance.

**Accountabilities - 1**:
**Deputy Qualified Person for Pharmacovigilance (Deputy QPPV)**

In the absence of the Qualified Person for Pharmacovigilance (QPPV):

- Establish and maintain the pharmacovigilance system and promote, maintain and improve compliance with the legal requirements
- Ensure and to verify that the information contained in the Pharmacovigilance System Master File (PSMF) is an accurate and up-to-date reflection of the pharmacovigilance system
- Oversight over the functioning of the pharmacovigilance system in all relevant aspects, including its quality system (e.g. standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance)
- Act as a single point of contact for the Regulatory Authority(ies) on all matters relating to pharmacovigilance and safety of marketed products including pharmacovigilance inspections (24-hour availability)
- Oversee the safety profiles of the company’s marketed products and any emerging safety concerns. Have awareness of any conditions or obligations adopted as part of the registration certificate and other commitments relating to safety or the safe use of the products

**Accountabilities - 2**:
**Pharmacovigilance (PV**)**
- Understand various functions of Pharmacovigilance and operational aspects
- Assist with day-to-day Pharmacovigilance operational activities
- Understand Individual Case Safety Reports (ICSRs) management and assessment as per internal procedures
- Act as case owner for assigned Individual Case Safety Reports (ICSRs) to ensure accurate completion of data entry (DE), data review (DR) and regulatory reporting (RR), in line with the company Standard Operating Procedures (SOPs) and Regulatory Authority Guidelines.
- Always to ensure the maintenance of a high standard of care quality processing
- Assist in conducting reconciliation of all adverse event reports received by PV from internal (Quality Assurance, Medical Information and reception) and external stakeholders (third parties)
- Support with the preparation of the Pharmacovigilance Standard Operating Procedures (SOPs)
- Assist in closing out all Corrective and Preventative Actions (CAPAs), Deviations and Change Control Actions on time as per internal company Standard Operation Procedures (SOPs)
- Assist in training of all Cipla employees and third parties (distributors/service providers) on Pharmacovigilance principles and reporting timelines
- Understand the Pharmacovigilance Agreement (PVA) / Safety Data Exchange Agreement (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 Pharmacovigilance function while upholding Cipla core values
- Follow-up on all Adverse Events/Adverse Drug Reactions related queries received from spontaneous/solicited reports within the timelines specified in company’s Standard Operating Procedures

**Accountabilities - 3 to 5**:
**Develops and Manages External Stakeholder Relationships**
- Complies with the requirements set out in the relevant Pharmacovigilance Agreements

**Develops and Manages Stakeholder Relationships**
- Identifies and develops key relationships with Cipla Global
- Leverage compliance expertise and alignment with Global Drug Safety

**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

**Education Qualification**:

- Passed and Completed Tertiary Degree: Degree or Diploma in Health Sciences
- 3 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 self-motivated and take responsibility for your own development
- To be a team player
- To be proactive

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