To provide Quality Assurance Support to DDReg’s Pharmacovigilance and Regulatory Services operations.
Duties and responsibilities
- Quality assurance support and expert advice to operational Pharmacovigilance (PV) and Regulatory Services activities within DDReg in order to ensure compliance with applicable regulatory requirements and DDReg procedures and quality standards.
- Support maintenance of the Pharmacovigilance System Master File (PSMF)
- Lead initiatives to maintain or improve quality performance and compliance of operational DDReg
- a) PV activities including case processing, medical safety, risk management, Health Authority reporting, PV IT systems and device vigilance; act as a quality champion.
- b) RA Activities including project deliveries, eCTD systems, Medical Writing and Review processes,
- c) Document archival system
- Lead and support initiatives focused on quality, process and compliance improvement.
- Through close collaboration with business partners, identify opportunities and develop strategies aimed at simplifying processes and improving quality while ensuring compliance with regulatory requirements.
- Ensure information gained during quality and compliance initiatives, as well as audit and assessment results, is evaluated to identify specific regulatory, compliance and QA training needs for business partners.
- Lead the development, implementation and conduct of appropriate training.
- Lead and support in the development of corrective and preventative action plans (CAPA)
- Monitor status of corrective and preventative actions to ensure the issues are adequately addressed, completed and appropriately documented.
- Provide assistance in the remediation of PV and/or RA-related deviations, ensure follow up and monitoring of associated corrective and preventive actions.
- Ensure quality and regulatory compliance issues are promptly communicated to appropriate management.
- Lead initiatives geared towards remediation of compliance concerns; determine effectiveness of remediation activities; provide ongoing project support and governance.
- Drive a culture of quality by close business partnering, to positively impact the business
- Effective coordination, facilitation and follow-up of HA inspections Successful management of the PV-related actions of the PV/RA Quality Plan Timely escalation through proper channels of issues and findings that impact DDReg’s PV,
- Effective collaboration on quality, compliance, remediation and improvement initiatives
- Timely review and feedback on policies, guidelines and procedures
- Timely and effective communication, consultation and support to business partners.es
Education & Experience
- Bachelor’s or Master’s degree in Pharma
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
- Experience working in the pharmaceutical/CRO industry preferred
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
As may be required from time to time – the incumbent may be required to working slots catering to different time zones
Reports to: Director