Pharmacovigilance Scientist
Location: Cambridge Massachusetts
Description: ARIAD is employing Pharmacovigilance Scientist right now, this vacancy will be placed in Massachusetts. Further informations about this vacancy opportunity please read the description below. The PV Scientist performs safety surveillance activities and provides scientific/clinical PV expertise with a focus on the identification, evaluation and management of safety risks for assigned ma! rketed and investigational products throughout the product’s lifecycle.
Duties and Responsibilities
Perform or contribute to signal detection activities for ARIAD marketed and investigational products including signal identification, evaluation, interpretation of safety signals and trends and communication (written and verbal) of safety risks
Collaborate with other applicable ARIAD functional area specialists including Biostatistics, Medical Affairs, Quality, Regulatory Affairs to identify, evaluate and manage safety signals for ARIAD marketed and investigational products
Manage the production and/or contribute to the development and maintenance of Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategy (REMS) as needed
Manage the production and contribute to the preparation of pre- and post- marketing aggregate safety reports including Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Repo! rts (PADERs), Development Safety Update Reports (DSURs), IND a! nnual reports, and 6 monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) reports
Contribute to health authority and other safety related query responses
Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g., Company Core Safety Information (CCSI), Investigator Brochure (IB), national labels, etc.)
Organize and prepare relevant material/data for Safety Management Team (SMT) and Product Safety Committee (PSC) meetings; ensure adequate documentation of meeting minutes
Support study teams for assigned ARIAD investigational and marketed products; serve as PV expert and liaise with Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities as needed
Contribute to the preparation and review of safety risk section(s) of Investigator brochures (IBs), protocols, inf! ormed consent/assent forms, clinical study reports/synopses, New Drug Application (NDA)/Biologics License Application (BLA)/Common Technical Document (CTD) submissions and other documents as needed
Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.)
Maintain knowledge of ARIAD disease and therapeutic areas for marketed and investigational products assigned
Ensure compliance with ARIAD and PVG & Risk Management policies and procedures
Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.
Requirements
Degree in Medicine, Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PVG.
Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, inc! luding 3 year experience in PVG.
Knowledge of MedDRA terminolo! gy and its application
Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data
Experience in safety issue/signal management
Proven ability to evaluate clinical/epidemiologic data
Experience in the preparation and authoring of pre- and post- aggregate safety reports, RMPs, and RSI
Thorough understanding of the drug development process and context applicable to safety surveillance activities
Excellent verbal and written communication skills as well as presentation and team-interaction skills are necessary
Proficiency in Microsoft Office
Knowledge and experience of common safety database systems
Strong commitment to business ethics
Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to ARIAD.
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Wed, 24 Jul 2013 22:59:34 GMT