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Associate Director, Global Pharmacovigilance Operations - Wyeth
Nov 07
Location: Collegeville, PACategories: Pharmaceutical
Website: http://www.wyeth.com
Position Description
Mission.
It’s more than a statement.
At Wyeth, we strongly believe in fulfilling our mission to bring to the world pharmaceutical, consumer, and animal health care products that improve lives and deliver outstanding value to our customers and shareholders. But it’s much more than words. It’s a commitment we make each day to help other people live better lives by building one of the industry’s strongest R&D pipelines, and offering such important products as Effexor® and Prevnar®. Your career says a lot about you. Take this opportunity to add real meaning to it.
We currently seek an Associate Director, Global Pharmacovigilance Operations at our Collegeville, PA location to be responsible for planning, directing, leading and coordinating the collection and reporting of adverse events for all Wyeth products worldwide.
RESPONSIBILITIES:
* Functions as a liaison between therapeutic areas within GSSE and Wyeth worldwide affiliates, Business Partners, Regulatory Agencies, Contract Research Organizations and other Wyeth departments.
* Assists in effective project management as determined by business needs and leads special projects which enhance team and/or departmental performance.
* Oversees and directs to ensure timely distribution of letters, regulatory reports and other information to Wyeth Affiliates, Business Partners, Investigators, Regulatory agencies and others, to meet worldwide regulatory requirements.
* Ensures that the teams distributes all adverse event reports according to SOPs to ensure compliance with worldwide regulations.
* Determine human resource needs for the team, as well as the effective management of these resources (hiring, development, performance, appraisals).
* Ensures that notification to investigators occurs on a timely basis.
* Ensures that Wyeth is in compliance with the FDA and ICH guidelines and EU directives for reporting Investigator letters.
* Interacts with other Wyeth organizations: namely CR&D, GMA, US Field Operations Group, WLV, etc.
* Provides training and education to Medical Monitors about the Investigator Letter process.
* Provides system enhancement requirements to GSSE IM & the S3 Application Support group and for ongoing training of the Investigator Letter team.
* Provides guidance regarding processes to internal and external departments as well as contractors and investigators.
* Determines human resource needs for the team, as well as the effective management of these resources (e.g. hiring, development, performance appraisals).
* Collaborates with various internal departments to develop system applications, SOP/SPI and t raining materials to achieve departmental goals and worldwide compliance.
* Participates, as needed, in preparation of various contracts and collaborates with the Contractual Agreement group.
REQUIREMENTS:
* BS/BA degree with 10+ years experience; MS/MA degree with 9+ years experience; or PharmD with 8+ years experience.
* Minimum of 10 years cumulative experience in clinical, safety surveillance or healthcare related field.
* Time/project/workload management experience.
* General managerial and leadership skills.
* Knowledge of federal regulations and ICH/CIOMS guidelines involving studies and post marketing spontaneous reporting with thorough understanding of pharmacology, disease processes, body systems, drug toxicity and drug interaction.
* PC proficiency.
* Global mindset with excellent analytical problem solving, interpretive and communication (verbal and written) skills.
* Demonstrated strong management and leadership skills with capability of working in a dynamic environment.
Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs.
For more information and to apply online,
please visit: www.wyeth.com
Wyeth is an Equal Opportunity Employer, M/F/D/V.
