Senior Pharmacovigilance Scientist (JHB North) at Aspen Pharma Group

KEY ACCOUNTABILITIES:

• 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 Aspen Pharmacare.
• 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).

Financial:

• 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.

Medical Writing Accountabilities;

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 Aspen SOPs and style guidelines.
• Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
• Safety

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. 

Labelling;

• Updating, reviewing and submitting of Product Information in line with the Company Core Data Sheets for Contractual Partners and Aspen (where required).

Aggregate Reporting:

• Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports for Contractual Partners and Aspen (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 Aspen (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 and Aspen (as required).
• Manage safety related requests from CRAs and Contractual Partners to ensure any requests are answered fully and promptly.

Literature Reviews:

• 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).

Training

• 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.

QMS and Compliance:

• 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.

General:

• Adhere to agreed Key Performance Indicators (KPIs).
• Support the continuous development and improvement of the PV function while upholding Aspen 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.
• Any other duties as assigned by your manager

Requirements

EDUCATIONAL QUALIFICATIONS & EXPERIENCE:

• B. Pharm 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