Job Description

Job Summary Bachelor of Pharmacy Degree
Documented experience in all aspects of pharmacovigilance is an inherent requirement and not negotiable
3-5 yrs. pharmaceutical experience with specific focus areas in PV/Drug Safety
Experience working with safety databases
Experience writing large safety reports e.g., DSURs, PADERs, PSURs, PBRERs is preferable
Experience in writing RMPs is desirable
Experience working with MedDRA coding dictionary
Delegated tasks from RA Manager or PV Lead on a defined and ad hoc basis with the flexibility of mind-set and time resource this entails. This will include representation at meetings when required.
Functional reporting: Mentoring of the other Pharmacovigilance Scientists
Review and advice regarding relevant local and global guidelines, policies, internal procedures, and SOPs across the company
Maintain awareness of Pharmacovigilance regulatory requirements and developments
Manage outsourced data collection, organisation, and preparation with vendors
Act as Subject Matter Expert (SME) in designated area (e.g. literature, signal management, aggregate reports, labelling etc.) responsible for oversight and coordination of tasks related to the area of expertise
Preparation of annual as well as ad-hoc and scheduled aggregate safety reports
Ensure Good Documentation Practice
Contribute to agreed PV Team quality and compliance targets
Serve in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs
Direct interaction with Regulatory Authorities and Contractual Partners
Ensure implementation of Contractual Partner requirements (as stipulated in the SDEAs)
Identification of project challenges to departmental line management and the financial impact thereof
Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost-effective
Work in collaboration with Medical Writers to write clinical documents for submission to regulatory authorities, including but not limited to:
Clinical overviews and summaries
Integrated summaries of safety and efficacy
Clinical Expert Statements
Provide medical editing review of draft and final documents prepared by other team members before internal or external distribution. This includes both copy editing and content review.
Ensure document content and style adheres to SAHPRA/FDA/EMA or other appropriate regulatory guidelines and complies with SOPs and style guidelines
Perform literature searches/reviews as necessary to obtain background information and training for development of documents
ICSR (Individual Case Safety Reports)
Ensure all cases are processed, medical reviews (where applicable) completed, and cases submitted to Health Authorities and Contractual Partners as per the timelines specified in the guidelines
Ensure quality checks are performed on weekly, monthly, quarterly, and bi-annual reconciliations with internal and external stakeholders
Updating, reviewing and submitting of Product Information in line with the Company Core Data Sheets for Contractual Partners and the company (where required)
Preparation of Risk Management Systems including but not limited to Risk Management Plans and Risk Communication Plans for/on behalf of Contractual Partners and the company (as required)
Responses to requests for information (RFI) from Competent Regulatory Authority (CRA) and Safety Communication (Dear Healthcare Professional Letters (DHCPLs)) for/on behalf of Contractual Partners (as required)
Manage safety related requests from CRAs and Contractual Partners to ensure any requests are answered fully and promptly
Monitor local literature for designated Contractual Partner products and identify safety issues/ ICSRs in a timely manner (for SADC including ZA)
Signal detection and notifications to Contractual Partners
Coordinate and prepare appropriately for signal management meetings
Signal Management Activities including compilation of Signal Assessment Reports/ Case series Reviews for potential signals
Creation, update and implementation of Safety Data Exchange Agreements (SDEAs)
Oversee training and mentoring of other Pharmacovigilance staff and prepare training materials
Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities
Maintain a high and up-to-date level of product and therapy area knowledge by attending conferences, training courses, reading relevant medical and scientific literature
Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs
Creation and update of SOPs/WIs for all pharmacovigilance activities related to the job role in line with Pharmacovigilance regulations/guidelines (EU, ZA and SADC) and pharmacovigilance agreements, within specified SOP timelines
Update of the PSMF annually and the PSMF annexures quarterly to ensure all changes for Contractual Partners are included once new Pharmacovigilance agreements are finalised
Monitoring Contractual Partner compliance
Adhere to agreed Key Performance Indicators (KPIs)
Support the continuous development and improvement of the PV function while upholding core values
Effective management and utilisation of resources to keep processes cost effective
Collating data for ad hoc requests
Adherence to Company Health & Safety procedures
Participate in training programmes

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