Drug Safety Manager (Program Lead) CONTRACT

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POST DATE 9/16/2016
END DATE 10/15/2016

Alkermes Waltham, MA

Waltham, MA
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Full Time
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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes website at www.alkermes.com .

Position Summary:

As a highly visible member of our team, The Drug Safety Manager in the capacity of a Program Lead will have the following responsibilities:

* Safety Lead on programs

* Attend clinical team meetings as safety representative

* Oversight and project training of Safety Specialists

* Oversight over ICSR case processing activities

* Oversight of vendors and business partners

* Oversight and support of reconciliation activities

* Performing continuous quality improvement initiatives to ensure data consistency and a high level of data quality.

* Work within cross-functional teams to ensure no issues within post-market and clinical trial activities

* Review clinical trial reports

* Provide input on aggregate reports

* Support safety signaling information to PV Risk Management group

* Train to SOPs

* Author Safety Management Plans for assigned studies

* Compile information for Safety Review Meetings and facilitate (weekly/monthly) meetings with project team (PV MD, Medical Monitor, Clinical Project Manager)

* Health authority responses - Compiling and supplying as requested, safety information for Regulatory submissions such as IND (Investigational New Drug) safety reports, Annual Safety reports, DSUR/PSUR, or clinical study reports.

* SME for audits and inspections

* This role is an individual contributor

Minimum Basic Qualifications:

* A clinical degree (e.g., RPh/PharmD, BSN, RN )

* 5+ years drug safety or clinical safety experience

* Two years clinical experience in a medical setting, demonstrate general medical and pharmacology knowledge

Preferred Competencies and Qualifications:

* Have demonstrated knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidances related to pharmacovigilance and Good Clinical Practices

* Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge

* Competence with Argus commercial safety application database

* Ability to work effectively as an individual contributor and as project team member

* Is proactive, demonstrate ability to independently identify problems and effectively offer solutions

* Has the ability to work independently with minimal supervision, able to multi-task with attention to detail,

* Excellent interpersonal, communication, and personal organization skills; ability to prioritize workload and work effectively, sometimes within resource constraints

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.