Pharmacovigilance Manager - Office based, Bulgaria
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Job Summary:
Manages personnel within Pharmacovigilance and has expertise with regards to the tasks of the subordinated group (е.g. may be able to provide services for Serious Adverse Events (SAE)/Adverse Reactions/Medical Device Report management in writing or by phone, periodic safety reports, adjudication, coding, product complaints). Supports departmental initiatives and development of SOPs, investigation of process-related issues, consulting on safety processes, tools, and regulatory compliance. Maintains familiarity with current industry practices and regulatory requirements that affect services provided by Pharmacovigilance. Ensures that staff fulfill their responsibilities in accordance with company policies, procedures, and SOPs.
Responsibilities:
• Supports direct reports in monitoring of their projects to assure company profitability and associated project goals and objectives are being met.
• Develops, implements, and monitors profitability, objectives, metrics of assigned group of direct reports.
• Identifies and implements improvements of processes within the assigned service are through review of project specific plans and their implementation; recommends improvement plans to project.
• Manages resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual obligations.
• Analyzes current and future project backlog in order to provide adequate resources to meet business objectives.
• Builds and aligns a technical team to perform critical operating tasks to achieve results.
• Identifies and implements process improvements and other ways to improve efficiencies.
• Provides technical oversight of the generation of project plans such as but not limited to Safety Management plans (SMP), or SAE Reconciliation plans, in close cooperation with project team during set-up phase.
• Delivers training on department related topics as well as general company processes and systems to Pharmacovigilance staff.
• Liaises with other functional managers to ensure consistency of safety management approaches within the company.
• Maintains familiarity with current industry practices and regulatory requirements that affect services provided respective service area.
• Reviews Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager and Pharmacovigilance Project Lead, Pharmacovigilance Assistants, group-related project tasks; provides leadership in the delivery of related services to clients.
• Ensures that staff fulfill their responsibilities in accordance with company and/or client QMS, policies, procedures, and SOPs, as applicable.
• Creates an environment that encourages learning, self-improvement and career development for staff.
• Supports the development and implementation of training for Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager and Pharmacovigilance Project Lead, Pharmacovigilance Assistants, or other personnel within the assigned service area.
• Recommends and supports implementation of performance and productivity improvements within the assigned service area to ensure optimal utilization of billable staff.
• Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes.
• Identifies and implements process improvements through review of SOPs, processes; recommend improvement plans to senior management.
• Participates in task forces to implement process improvement initiatives.
• Builds teamwork and improves process and productivity by working within and across functional areas.
• Develops company employees to ensure high quality work performance and retention of high quality employees.
• Ensures staff development and performance feedback are provided through activities such as mentorship and career development.
• Communicates team/individual goals and expectations to ensure direct reports understand their responsibilities.
• Involved in the recruiting processes for new employees in the assigned service area.
• Assists with bringing new business opportunities to the company and maintaining existing clients’ relationships for repeat business.
• Interacts with clients and participates in client meetings as necessary to support and maintain new business.
• As assigned, participates in business development initiatives, including presentations and proposal development.
• Ensures that timely and accurate information is submitted on all proposal efforts.
• Participates in business development initiatives, including presentations and proposal development.
• Supports direct reports and senior management during audit preparation and conduct. Responds to audit findings as needed.
• Prepares Standard Response letters, including conducting literature search, article summary etc.
• Responsible for vendor management
• Supports Qualified Person for Pharmacovigilance as required.
To be successful you will need:
• Bachelor’s degree (or higher) in a healthcare-related or life science field.
• A minimum of 3 years’ experience being Pharmacovigilance manager within a CRO or BPO.
• Broad knowledge of clinical development and/or safety requirements from pre-clinical to post marketing.
• Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.
• Excellent Project Management skills.
• Analytical mindset.
• Excellent command of English.
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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
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