Pharmacovigilance Scientist (413-419)
ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.
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 marketed 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 Reports (PADERs), Development Safety Update Reports (DSURs), IND annual 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, informed 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
- 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, including 3 year experience in PVG.
- Knowledge of MedDRA terminology 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
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ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.