Pharmacovigilance/Regulatory Pharmacist - Midrand
This role will be supporting both the Pharmacovigilance as well as the Regulatory Department with a 50/50 split.
Pharmacovigilance Accountabilities (Deputy to LPVM):
Assist the local Pharmacovigilance Manager (LPVM) in maintaining a compliant PV system.
Ensuring the compliance with respective legislation at all times for all relevant countries.
Implementation of company global and local procedures.
Assume PV responsibilities for local activities for Clinical Trials (CTs), Investigator Initiated Studies (IIS), Non-Interventional Studies, Compassionate Use Programs / Early Access Programs, Non-Trial Activities and Post Authorization Safety Studies.
Act as a deputy in the absence of Qualified Person for Pharmacovigilance (LPVM) to local Authorities, whenever required by local regulations
Ensure local safety data collection and safety reporting, including receipt, processing, distribution, tracking, archiving and follow-up of safety information locally, according to the company procedures and regulations.
Entering data into respective databases ensuring high accuracy and attention to detail.
Reporting of relevant individual case safety reports and safety periodic reports to Regulatory Authorities and Ethic Committees, according to local requirements.
Screening of local literature for adverse event information.
Review of local customer related screening system results for adverse event information.
Reconciliation with key partners, e.g. Product Complaints and Medical Information.
Monitoring and testing of sponsored and company owned websites.
Handling of regulatory safety requests and any other safety inquiries/issues in close collaboration with local management, ROPU and Regional PV Heads.
Assist in the reporting and investigation of non-compliances
Contribute to corrective and preventative action preparation and follow-up processes, whenever applicable
Assist with Local inspection readiness
Assist with handling of local PV audits
Assist with the contribution as appropriate at a local level for implementation and monitoring of risk minimization measures for all products
Responsible for allocated product portfolio.
Compilation and submission of new product applications, line extensions and/or new indications in line with the business plans/projects and as per the regulatory timetable in order to ensure Timeous registration and launch of new products in the respective countries.
Submission of Package Insert/Patient Information Leaflet updates for registered products within the required time lines in order to ensure that the product package insert contains the most recent Safety data and other relevant information.
Life-cycle management: submission of post-registration variations and/or dossier renewals for registered products within the required time lines in order to ensure regulatory compliance in line with local Health Authority regulations.
Ensure rapid communication to relevant colleagues in the case of a change in regulatory
submission or approval time lines and/or potential regulatory related risk to the overall business.
Review of regulatory documents/dossiers received from Global RA or third party companies and communication of additional data requirements for South Africa, Namibia and Botswana.
Submission of PSUR's & DSUR's in line with the respective Corporate and Health Authority
Requirements and within the prescribed time lines.
Maintenance of the product master files.
Proof-reading of artwork (via the AMT system) in line with corporate time lines; proof-reading of MIMS and MDR as required.
Ensure cross-functional teamwork and collaboration (e.g. support of launch meetings and plans, tender applications where relevant, regular communication/updates, participation in brand plan meetings, business meetings, etc.) with all stakeholders involved in the business, e.g. management, marketing, medical, quality, supply chain, etc.
Remains constantly involved with the dynamics of the regulatory affairs environment via active participation and involvement in local professional associations e.g. SAPRAA, SAAPI, etc.
Constantly monitors the regulatory environment in the respective countries by studying and/or commenting on draft or new regulations, guidelines, documents etc. issued by the relevant Health Authorities.
Ensure that the relevant Corporate Databases (e.g. RequireBase, GVD, etc.) for the countries/products are updated and maintained within the stipulated time lines.
Ensure compliance with all corporate, regional and local SOPs, Procedures, KMeds, etc.
Ensure R&U of all required SOPs, Policies, etc. in LOS within the prescribed time lines.
Ensure compliance with CAPA requirements and time lines.
Develop a Quality excellence culture within the SA Regulatory operation.
Maintain data integrity of corporate systems and databases such as CPD3, SLCI, AMT, etc.
Minimum Education/Degree Requirements
Required Capabilities (Skills, Experience, Competencies)*
Minimum 4 years of experience in pharmacovigilance and regulatory affairs in the pharmaceutical industry
Customer approach with high business understanding
Result orientation and managing ambiguity in a difficult situation
Creativity on finding solutions with 'can do' approach
Setting direction and leading change
Managing people; attracting and developing talents
Successful applicants will be contacted within a week