Pharma Dynamics Recent Job Opportunity – Apply Now!

We at Pharma Dynamics seeks to employ an experienced Regulatory Pharmacist to manage the compilation, submission of ARV/TB range of products in line with current legislation, operational requirements and business needs of Global Institutional Business.

 

Job Title: Regulatory Pharmacist
Location: Tokai, Western Cape, South Africa
Reference: # RAP 2020
Contract Type: Contract 12 Months
Salary: Market Related

Specification
UNDERTAKE THE RESPONSIBILITIES BELOW at a high level of functioning with minimal guidance:

Dossier management
•Manage the timeous compilation and submission of any due diligence report in line with allocated product priorities
•Provide technical assistance to Global Institutional business in line with South African Regulatory requirements and dossier format
•Assist, in liaison with the Responsible Pharmacist, Quality Assurance and Compliance, Cape Town, the compilation and availability of all technical and/or pharmacovigilance agreements prior to the submission of new dossiers
•Manage the GmP compliance of API’s and manufacturers on an ongoing basis and ensure any deviations or potential quality risks are communicated to the Responsible Pharmacist
•Manage the implementation of artwork and patient ready packs, in line with tender requirements and in liaison with the Responsible Pharmacist and State tender Manager
•Compile and submit any TB and/or ARV dossiers within the agreed timelines to SAHPRA and/or neighboring countries
•Ensure any variations are logged on the CCP register and managed until completion
•Ensure an appropriate ongoing stability program is in place in liaison with the Technical Specialist and QA manager
•Identify and manage the implementation of CAPAs in liaison with Quality Assurance and/or Regulatory
•Ensure all dossier related procedures, templates and quality standards are adhered to
•Maintain the product life cycle on an ongoing basis
•Manage and ensure implementation and availability of all pre- and post-registration SAHPRA commitments including, but not limited to validation reports, stability data and batch documentation
•Ensure all correspondence and or dossier information are communicated to the administrative department thus ensuring electronic database updates
•Ensure all packaging material is current, in line with latest SAHPRA approvals and stored electronically for South Africa and neighboring countries
•Manage the compilation of all tender related SOP’s including new SOP’s, updates to existing SOP’s and reviews of outdated SOP’s in liaison with Regulatory Affairs, Quality Assurance and the Responsible Pharmacist
•Maintain an accurate product history and ensure the electronic database for regulatory dossiers are current and accurate

External stake holders

•Liaise with the South African Regulatory Authority with regards dossier recommendations, biostudies and/or clinical trials
•Assist in collaboration with the Responsible Pharmacist and Tender Manager with any technical matters relating to tender requirements involving the Department of Health

Technical queries and complaints
•Manage, in liaison with PV Manager, and Responsible pharmacist all product related technical queries internally and from consumers or other healthcare professionals.

Marketing support:
•Ensure factual and legislative compliance of all product related training material in liaison with the Compliance Department

General
•Perform any other duties as per changes in operational requirements of the department.
•Perform any other duties as requested
•Provide monthly and or weekly reports as and when required
•Assist with collating and providing financial requirements for budget purposes

Requirements
PRE-REQUISITES
•B. Pharm registered with the SA Pharmacy Council
•Scientific degree with at least 2-3 years hands on experience within a Regulatory environment

TECHNICAL COMPETENCIES REQUIRED

•Good knowledge of the Pharmaceutical industry and tender business
•Ethical clinical trial experience
•Good command of neighbouring country registration process
•Computer literate and able to effectively use Excel, Word, Power point
•Holds considerable technical expertise
•Makes very few technical / functional errors
•Produces a high volume of work at a consistent standard
•Managerial or supervisory experience
•Presentation skills

BEHAVIOURAL COMPETENCIES REQUIRED

•Effective project management and process flow skills
•Effective leadership and people management skills, including motivating staff and managing staff performance
•Functions independently at a senior level
•Displays appropriate judgment and expertise to problems at hand
•Proactively anticipates problems and solves them constructively
•Effectively balances technical and commercial requirements with minimal supervision
•Professional and presentable
•Effective written and verbal communication skills
•Highly organized and good planning skills
•Self-discipline and effective administration skills
•Highly accurate and has good attention to detail
•Positive attitude and self-motivated

The company reserves the right to adjust or modify the scope and / or level of the job based on applicant supply, operational requirements and/or prevailing market conditions.

To apply

Click Here!

Application Deadline:  30/04/2020

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