Country Safety Lead - fixed term contract

Pfizer
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București
Responsabilities:


  • Provide guidance, lead/co-lead projects, manages own time to meet objectives, plan resource requirements for projects across the division.

  • Mange the development and maintenance of Country Quality Plan.

  • Provide oversight and guidance to colleagues on review and processing of adverse event reports.

  • Support local, internal and external safety activities in collaboration with internal and external stakeholders.

  • Act as Business Management Subject Matter Expert for procedural documentation and training for Safety Evaluation and Reporting (SER), provide support also in identifying SER SMEs to support these tasks and collaborate with ST in managing effective rollout of processes across SER.

  • Manage resources in the safety team depending on local organization and safety group size and conduct follow-up.

  • Manage completion of safety-related reports to determine the safety profile of Pfizer's products and to meet regulatory requirements.

  • Support audits, regulatory inspection and related requests, when applicable.

  • Ensure timely and accurate handling of individual and aggregate reports to meet corporate and regulatory reporting requirements for the country.

  • Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database.

  • Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and lead continuous inspection readiness efforts in collaboration with applicable headquarters inspection management teams.




Qualifications


Must-Have


  • Bachelor's Degree

  • 5+ years' experience

  • Experience in pharmacovigilance and/or data management, clinical care or clinical or scientific research

  • Knowledgeable in pharmaceutical business, including drug development and regulatory aspects

  • Good understanding of international regulations and of worldwide reporting requirements

  • Demonstrable organizational and time management skills, in order to meet strict regulatory compliance goals

  • Demonstrable problem solving and decision-making skills in complex situation.

  • Demonstrated computer literacy, particularly in the use and management of relational databases

  • Fluent in spoken and written English




Nice-to-Have


  • Master's degree

  • Relevant pharmaceutical industry experience

  • Managerial experience in hospital or pharmacy, and familiarity with clinical assessment

  • Knowledge of training design and tools and experience in applying training methodology

  • 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



GJL 070




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




Pfizer colleagues in different countries work together to improve the health of people all over the world. We are constantly working on the development of innovative therapies and growth opportunities, being in continuous search of new talents





Flexible Work Environment




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
#LI-PFE

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