Clinical Safety Specialist (AdvancedGroup_410035) Cambridge, Massachusetts
Job Number: 410035
Clinical Safety Specialist
Responsible for Pharmacovigilance Operations activities for all safety reports received from any source (clinical trials and post-marketing) for assigned products and/or studies, according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies and procedures.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each key function satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the key functions as determined through an interactive discussion with the employee and in consultation with HR and Legal.
• Ensures accuracy of triage, assessment and processing of adverse events in the Global Safety Database
• Ensures compliance with federal regulations and standard operating procedures.
• Collaborates with medical staff regarding adverse event/safety issues.
• Represents Pharmacovigilance on Clinical Trial Working Groups (CTWG) for assigned products
• Collaborates with cross-functional teams to create IND reports and aggregate reports
• Communicates with partner companies, collaborative sponsors and respective clinical research organizations (CROs) regarding evaluation and processing of case reports
• Determines necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge and ensures that required follow-up for assigned cases has been completed;
• Assist with the expedited reporting of individual case safety reports to regulatory authorities, partner companies, and other trading partners, as needed, to ensure compliance with regulatory and company timelines
• Collaborates with appropriate Data Management, license partner or CRO personnel to ensure that key data fields are reconciled between the clinical and Pharmacovigilance databases and assists in resolving discrepancies
• Assists in the preparation of periodic and annual safety reports and investigator communications
• Assists in the generation of safety line listing reports, summary tabulations, and/or metric reports for company management, partner companies, and collaborative sponsors, as needed
• Assists with the maintenance of the Pharmacovigilance database, including participation in validation and implementation activities for system upgrades and maintenance of the database user manual
• Liaise with 3rd- party vendor in development and maintenance of trial or program-specific safety management plans
QUALIFICATIONS: The requirements listed below are representative of the knowledge, skill and/or ability required.
• Degree in healthcare discipline such as an, RN, Nurse Practitioner, Physician Assistant preferred
• Healthcare background required (BS/RN/NP/PA/RPH)
• Strong clinical background required, oncology experience preferred
• Understanding of local and applicable foreign safety regulations
• Working knowledge of relevant regulations and guidance documents governing both safety reporting and processing for clinical trial and post-marketing environment
• Detailed knowledge in the use of drug safety databases (Argus)
• Individual case-processing experience
• Relevant experience in adverse event processing in both investigational and post marketing safety surveillance environments required
• Good knowledge of medical terminology highly desirable
• Practical experience working with MedDRA required
• Ability to collaborate with partners and teams with members from multiple disciplines
• Time and project management skills
• Ability to work in a cross-functional team in a matrix environment
• Excellent interpersonal, influencing and negotiation skills
• Strong verbal and written communications and presentation skills
• Proven problem solving and decision making skills
• Excellent leadership, management, planning and project management skills
• Ability to interact effectively with staff of multiple disciplines both within and outside the company both nationally and internationally
• Ability to in a high-pressure, fast paced and changing environment to ensure objectives are met in a timely manner and achieved within budget allocations
PHYSICAL DEMANDS: (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions) as determined through an interactive discussion with the employee and in consultation with HR and Legal.
• Ability to sit and stand for long periods of time.
• Carrying, handling and reaching for objects.
• Ability to lift and carry over 15 pounds.
• Manual dexterity to operate office equipment i.e. computers, phones, etc.
• Access to transportation to attend various meetings held in proximity to the offices
Interested candidates please send resume in Word format to firstname.lastname@example.org Please reference job code 410035 when responding to this ad.