Senior Safety Data Management Specialist

Why Patients Need You
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
You will be relied on by the company to monitor its drug, biologics and medical devices surveillance program. This will include intake, evaluation and processing of the adverse reports received. You will support the clinical trial as well as the post marketing activities.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.
It is your dedication and hard work that will make it possible for Pfizer's customers and patients to receive the medicines they need, when they need them.
How You Will Achieve It

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Provide oversight, team mentoring on case handling aspects, data extraction and analyses and conduct follow-up activities.
• Act as subject matter expert and liaise with key partners regarding safety data collection and data reconciliation.
• Review, analyze, prepare, and complete safety-related reports within scope to determine the safety profile of Pfizer's products and to meet regulatory requirements.
• Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios.
• Manage, where applicable, safety resources in the local team.
• Provide specific pharmacovigilance or product knowledge and experience, as required by the business, and mentor colleagues accordingly.
• Develop and maintain advanced knowledge of all products within the Pfizer portfolio.
• Develop and maintain expertise of all assigned products, of applicable corporate policies.
• Design and oversee the tracking of applicable safety metrics.
• Manage project and process management meeting established deadlines.
• And search functions in the safety database and data mart.
• Participate, as appropriate, in local, internal and external safety activities
• Carry out case processing activities
• Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments
• Review case criteria to determine appropriate workflow for case processing
• Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
• Write and edit case narrative
• Determine and perform appropriate case follow-up, including generation of follow-up requests
• Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios

Qualifications
Must-Have

• Bachelor's Degree
• Pharmacist
• 3+ years' experience
• Demonstrated organizational/project management skills
• Solid knowledge of global regulations and guidelines for drug development
• Demonstrated analytical and statistical skill.
• Ability to make decisions independently and resolve issues appropriately
• Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
• Fluent in spoken and written English

Nice-to-Have

• Master's degree
• Relevant pharmaceutical industry experience
• Familiarity with management of performance metrics
• Ability to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact

#LI-PFE
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
School of Leaders
We, as Pfizer Turkey, make a difference with our visionary and pioneering approaches ranging from our concept of raising leaders through rotations, providing international career opportunities to creating a flexible, enjoyable work environment. There are no limits to what we can accomplish to touch lives here!
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Medical