14 days old
2018-07-312018-08-30

Country Drug Safety Lead (m/f/d)

Pfizer
Berlin, NH
A role at Pfizer is unlike any other. Offering talented individuals the opportunity to own a career with real impact, our people go to work each day in the knowledge that every development signifies real, positive progress. We all believe in our ability to improve the future of healthcare, and in our potential to transform millions of lives. Because in every part of the world, the work we do is reaching everyone, everywhere for almost every medical need.



This is what you can expect:



+ Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Pfizer products and to meet regulatory requirements.

+ Contact point in the country, internally and externally, for safety-related aspects.

+ Manage resources in Germany

+ Efficient, high-quality execution of safety-related activities

+ Performance towards corporate functions and local compliance towards regulatory bodies

+ Efficient management of resources in the Drug Safety Unit (DSU)

+ Ensure fulfilling of drug safety-related obligations for the country

+ Where required by regulations, act as local contact or local QP PV

+ Participate in country activities as DSU point of contact for Pharmacovigilance Business Line

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

+ Ensure timely handling of local safety issues; manage local safety issues in collaboration with central safety functions and local stakeholders

+ Support timely handling of local safety-related regulatory requests

+ Maintain expertise in country as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the country

+ Act as country's point contact for Safety, internally and externally

+ Represent Pfizer pharmacovigilance in local industry associations and other external groups

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

+ Monitor, and actively conduct as needed, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency and any other required country-specific safety activity

+ Monitor and conduct as needed, local materiovigilance activities, including medical device incident monitoring and reporting as required by local agency, and any other required country-specific device safety activity

+ Organize and manage the country safety group to ensure effective coverage of safety-related activities

+ Develop and maintain knowledge of applicable SOPs, CP and other procedural documentation

+ Provide guidance to the country group for standardization of processes and goals

+ Manage and monitor the effective rollout of processes

+ Facilitate resolution of concerns and questions

+ Mentor colleagues on the effective use of the corporate safety database

+ Organize and manage inspection readiness activities in the country

+ Take responsibility for implementing corrective actions resulting from timeliness or quality issues associated with safety-related activities for the country

+ Support the standardization and quality of local safety data exchange agreements

+ Monitor and manage training of DSU, and ensure coaching and mentoring

+ Organize and manage recruitment for the DSU; fully utilize corporate tools, to manage the performance reviews of assigned colleagues in the country

+ Manage and monitor cost of the country team and relevant safety activities



What we are looking for:



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

+ Good understanding of medical and scientific terminology

+ Degree / Advanced degree in medicine or in life sciences or equivalent experience

+ Several years of experience in the pharmaceutical industry in pharmacovigilance or clinical research or product development

+ Rational approach to issues and their business implications

+ Good problem solving and decision making skills

+ Team building and team management experience

+ Strong interpersonal skills, with a demonstrated ability to manage people and foster teamwork

+ Excellent communication and negotiation skills - ability to manage discussions and decision making across cultures

+ Highly skilled in time management and change management, organizational and facilitation skills

+ Ability to meet personal objectives while meeting departmental standards of performance

+ Comfortable working in a matrix environment

+ Fluent German and English language skills



If you enjoy delivering ambitious results and seeing challenges as an opportunity for personal development this might be the position you have been looking for. Working together we will advance the science to improve the outlook for patients worldwide.



Please apply only via our online career website.



in case of questions, please contact Cathleen Klemt (Talent Acquisition Manager), cathleenramona.klemt@pfizer.com, Tel.: 030 550055 53374



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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Country Drug Safety Lead (m/f/d)

Pfizer
Berlin, NH

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Country Drug Safety Lead (m/f/d)

Pfizer
Berlin, NH
US

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