[UAE] Senior Consultant – Pharmacovigilance SME
ملخص الوظيفة
The role requires a strong blend of pharmacovigilance subject matter expertise regulatory and healthcare-sector knowledge consulting-style project delivery capability and stakeholder management. The successful candidate will be able to translate complex pharmacovigilance and regulatory expectations into practical frameworks processes documentation tools training materials and client-ready deliverables.
The ideal candidate will bring hands-on experience in pharmacovigilance drug safety regulatory compliance safety reporting PV quality systems risk management and PV operating model design or improvement. They will be comfortable working with clients regulators pharmaceutical companies healthcare organizations and cross-functional project teams.
The Pharmacovigilance Manager will play a central role in ensuring that PV-related content assessment logic stakeholder materials training outputs and project deliverables are technically robust practical and aligned with the clients expectations.
Critical Capabilities
- Strong understanding of pharmacovigilance principles regulatory expectations and operational best practices.
- Knowledge of adverse event intake ICSR management seriousness assessment follow-up reconciliation MedDRA coding quality control and regulatory reporting considerations.
- Understanding of signal detection signal validation risk management risk minimisation periodic safety reporting literature monitoring safety governance and PV system documentation.
- Familiarity with PV quality systems SOPs training deviation management CAPA audits vendor oversight document control inspection readiness data integrity and records retention.
- Ability to interpret and translate complex regulatory operational and healthcare requirements into practical assessment criteria guidance templates and client-facing outputs.
- Strong consulting-style problem solving with the ability to structure ambiguous issues and convert them into clear workplans deliverables and decisions.
- Experience supporting regulatory implementation compliance assessment maturity modelling gap analysis operating model design or process improvement initiatives.
- Strong stakeholder engagement and facilitation skills including the ability to work with public-sector regulatory pharmaceutical healthcare technology and quality stakeholders.
- Ability to produce high-quality written outputs including reports frameworks process documentation guidance materials training content executive presentations and decision papers.
- Strong project management discipline including planning action tracking risk management issue escalation and delivery against timelines.
- Ability to work in a multi-stakeholder cross-functional project environment involving PV regulatory quality digital data and client teams.
- Cultural awareness and ability to operate effectively in UAE GCC or international healthcare and regulatory environments.
Qualifications :
- Bachelors degree in pharmacy medicine life sciences biomedical sciences public health healthcare management regulatory affairs or a related field.
- Significant professional experience in pharmacovigilance drug safety regulatory affairs clinical safety healthcare quality life sciences compliance or related healthcare disciplines.
- Demonstrated experience supporting pharmacovigilance systems PV operations PV compliance PV quality systems safety reporting or regulatory readiness activities.
- Strong understanding of global pharmacovigilance standards and recognised international PV guidance and best practices.
- Experience developing reviewing or implementing PV policies SOPs process maps guidance documents assessment tools quality documentation or training materials.
- Experience working with or for health regulators ministries of health public health authorities pharmaceutical companies CROs hospitals healthcare consulting firms or life sciences organisations.
- Strong written and verbal communication skills including the ability to produce client-ready deliverables technical summaries executive presentations training materials and stakeholder communications.
- Experience working in the UAE GCC or broader Middle East healthcare or life sciences environment.
- Familiarity with healthcare regulatory environments and public-sector healthcare transformation programmes.
- Experience supporting public-sector healthcare regulatory authority or national health-system strengthening projects.
- Relevant professional certifications in pharmacovigilance regulatory affairs quality clinical research project management or related disciplines are desirable but not mandatory.
- Arabic language capability is advantageous but not required unless specified by client or project requirements.
Professional Competencies
- Strategic thinker with the ability to connect pharmacovigilance requirements to broader healthcare system regulatory operational and sector development objectives.
- Structured problem solver who can break down complex regulatory and operational topics into practical components clear recommendations and actionable deliverables.
- Client-service oriented with strong judgment responsiveness and commitment to delivering high-quality outcomes for the client and project stakeholders.
- Delivery-focused and accountable with a proactive approach to identifying risks resolving issues and maintaining momentum.
- Adaptable and comfortable working in a fast-paced consulting or project environment with evolving requirements and stakeholder needs.
AI Fluency
- Demonstrated AI fluency and comfort using AI-enabled tools to improve regulatory research pharmacovigilance analysis documentation synthesis presentation development project delivery and internal operations.
- Ability to assess how AI data analytics automation and digital tools can support pharmacovigilance compliance assessment regulatory requirement mapping gap analysis dashboarding reporting and knowledge management.
- Comfort working with data dashboards reporting outputs technology-enabled workflows and digital assessment tools.
Work Authorization / Location Preference
- Preference will be given to candidates already or willing to be based in the Abu Dhabi UAE.
- Candidates must have or be eligible to obtain the appropriate work authorization for the UAE.
- Ability to travel as needed for client meetings workshops stakeholder engagement sessions training activities testing and project delivery.
- Flexibility to work across remote and in-person delivery models with regular availability for client and stakeholder engagement.
Additional Information :
Joining Sia means integrating into a globally recognized firm that fosters personal growth through our unique Sia Village concept which promotes a community-driven culture reinforced by values of Excellence Entrepreneurship Innovation Teamwork Care & Support and Employee Wellbeing ensuring a fulfilling career path.
What a career at Sia offer you
- Competitive compensation: an competitive salary and benefits package benchmarked against the market to ensure the most competitive offers.
- Entrepreneurial spirit: Join us on an entrepreneurial journey that not only fosters innovation but also empowers you to drive your own success. Dive into a culture where your ideas shape the future.
- Tailored career advocacy program: Receive dedicated support designed to help you achieve your professional aspirations. Our program pairs you with mentors who provide actionable feedback ensuring continuous progress and success in your career path.
- Continuous growth: Engage with ongoing opportunities for learning and development particularly in new and emerging topics. Stay ahead of the curve by continually advancing your knowledge and skills.
Our Commitment to Diversity
At Sia we believe in fostering a diverse equitable and inclusive culture where our employees and partners are valued and thrive in a sense of belonging. We are committed to recruiting and developing a diverse network of employees and investing in their growth by providing unique opportunities for professional and cultural immersion. Our commitment toward inclusion motivates dynamic collaboration with our clients building trust by creating an inclusive environment of curiosity and learning which affects lasting impact.
We are guided by the pursuit of understanding and take pride in being able to provide meaningful solutions to our clients unique challenges. We bring our whole selves to work and strive to listen observe understand and be understood.
To learn more about our mission values and business sectors please visit our website.
Sia is an equal opportunity employer. All aspects of employment including hiring promotion remuneration or discipline are based solely on performance competence conduct or business needs.
Remote Work :
No
Employment Type :
Full-time
عن الشركة
Sia est un groupe international de conseil en management de nouvelle génération. Fondé en 1999, nous sommes nés à l’ère du numérique. Aujourd’hui, nos services en stratégie et management sont augmentés par la data science, enrichis par la créativité et guidés par la responsabilité. No ... اعرض المزيد