Pharmacovigilance Scientist at Aspen Pharma Group

To provide support to the Pharmacovigilance Manager for the various Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all Aspen products across the Pharmacare entity of the Aspen Group for which marketing authorizations are held. The role undertakes responsibility for coordinating and management of review and analysis of aggregate safety data concerning the Aspen Group product portfolio.

SPECIFIC OUTCOMES / ACCOUNTABILITY:

• Delegated tasks from Head of Pharmacare, PV Manager or Executive, 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.
• Review and advice regarding relevant local and global guidelines, policies, internal procedures and SOPs across Aspen Pharmacare.
• Manage outsourced data collection, organisation and preparation with vendors as required
• Act as Subject Matter Expert (SME) in designated area (e.g. literature, signal management, aggregate reports etc.) responsible for oversight and coordination of tasks related to that area
• Preparation of ad-hoc and scheduled aggregate safety reports
• Ensure Good Documentation Practice
• Maintain awareness of Pharmacovigilance regulatory requirements and developments
• 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

Financial:

• Identification of project challenges to departmental line management and the financial impact thereof

Medical Writing Accountabilities:

• Work in collaboration with Medical Writer 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 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:

• Creation and update of SOPs/WINs for all pharmacovigilance activities related to the job role in line with worldwide Pharmacovigilance and EU regulations/guidelines
• Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports
• Preparation of Risk Management Systems including but not limited to Risk Management Plans, Dear Healthcare Professional Letters and Risk Communication Plans
• Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly
• Review worlwide literature for designated products and identify safety issues/ ICSRs in a timely manner
• Coordinate and prepare appropriately for signal management meetings
• Signal Management Activities including compilation of Signal Assessment Reports/ Case Series Reviews for potential signals
• Creation and update of Safety Data Exchange Agreements (SDEAs

Training:

• Oversee training and mentoring of other Pharmacovigilance staff, and prepare training materials as requested
• 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 conference, training courses, reading relevant medical and scientific literature

General: 

• Monitoring the weekly literature
• Responding to Requests for Further Information from Regulatory Agencies
• Compiling periodic and addendum safety reports and Risk Management Plans
• Collating data for ad hoc requests
• Engaging in signal management activities
• Updating Product Information in line with the Company Core Data Sheets, and other tasks as designated
• Maintain rigorous adherence to written procedures, e.g.SOPs/WINs
• Adherence to Company Health & Safety procedures
• Participate in training programmes
• Any other duties as assigned by your Manager

Requirements

EDUCATION AND EXPERIENCE:

• Biological/life Sciences Degree or equivalent. B. Pharm essential
• Documented experience in all aspects of pharmacovigilance
• 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, PRBRERs, RMPs is desirable
• Experience working with MedDRA coding dictionary

COMPETENCIES – SKILLS & ATTRIBUTES:

• Pharmacovigilance practice and procedure
• EU Competent Authorities and Regulations
• Marketing Authorisation rules and regulations
• Knowledge of principles of epidemiology and statistics
• Good working knowledge of the relevant information sources: including printed publications, unpublished sources, databases, web sites, other departments, external bodies
• Good documentation practice
• Knowledge and information sharing
• Excellent attention to detail
• Excellent written and oral communication skills
• Understanding of the principles of information storage and retrieval and skill in their application
• Awareness of competitor products and activity. Excellent interpersonal and communications skills.
• A solutions provider with strong multi-tasking abilities
• Manage evolving deadlines effectively with regular feedback and updates.
• Enthusiasm and drive to take ownership and drive process initiatives.
• Occasional travel may form part of the job

ASPEN COMPETENCIES:

Business

• Make Good Decisions - Being solution orientated, innovative, agile and proactive. Good decisions are informed decisions
• Accountability/Ownership - employees readily accept responsibility, own decisions and achieve results despite adverse conditions 

People

• Communicate Effectively – Informal communications skills. Active listening skills, Writing skills, Presentation skills, Meeting facilitation, Empathy
• Leads and influence others – work collaboratively with others to achieve departmental goals 

Self

• Continuously Grows & Develops - staying competitive means continually increasing knowledge, skills and capabilities
• Takes action with Integrity - Aspen employees must internalise the principles of the Aspen Code of Conduct and demonstrate integrity, fairness, accountability, respect, transparency and sincerity