Medical Director - Safety/Pharmacovigilance - Oncology in Cambridge, MA at APEX Systems

Date Posted: 10/9/2019

Job Snapshot

Job Description

Job #:  1012148
Medical Director, Safety/ Pharmacovigilance, Oncology 1012148
Job Scope & Purpose:
Our long term, established oncology-focused client is seeking an experienced drug safety/ pharmacovigilance professional to join their collaborative team environment. Reporting to the VP of Clinical Development, the Director will lead the strategic management, planning, and execution of clinical pharmacovigilance and risk management activities for clinical development programs in compliance with regulatory guidelines. This individual will be responsible for the development and implementation of signal expertise through contributions to clinical deliverables and activities. The Director will provide scientific/clinical expertise, strategic input, and manage deliverables associated with signal management activities, safety, and benefit-risk evaluation, management of potential safety issues, evaluation of databases for safety signals.
Primary Job Responsibilities:
  • Develop and implement signal detection strategy; Lead the signal management process and evaluate safety data and signals as part of ongoing pharmacovigilance activities.
  • Lead aggregate report management including strategy, review and finalization of safety reports such as DSURs and annual reports and demonstrates effective leadership skills with cross-functional partners to ensure aggregate reports are of high quality and submitted according to required timelines
  • Plans an executes literature surveillance
  • Support safety-related activities for clinical trials including but limited to review and assessment of safety cases, writing narratives, and contributing author to protocols, ICFs, statistical analysis plans, safety content of Investigator Brochure and clinical study reports
  • Evaluate medical coding of safety data
  • Review standard design of tables, figures, and listings for safety data from clinical studies
  • Support data safety monitoring board activities, as applicable
  • Provide safety content for regulatory filings, including review of the safety and benefit-risk sections, review, and preparation of relevant safety sections to ensure consistency across documents and support response preparation
  • Oversight of CRO and vendors responsible for operational activities related to safety
  • Participate in cross-functional clinical study management teams and program meetings
  • Develop and implement pharmacovigilance SOPs
  • Participate in the quality management system in Drug Safety including ensuring department standards are met, including developing SOPs, training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
  • Ensures adherence to regulations, internal SOPs, and Drug Safety/PV agreements

Primary Job Requirements:
  • M.D. degree required
  • Minimum of 8 years of pharmacovigilance experience with at least 5 years managing medical case review and signal detection in a biotech/pharmaceutical setting
  • Thorough knowledge of FDA and ICH guidelines
  • Proven experience working with within a cross-functional team environment
  • Knowledge of MedDRA terminology and its application

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. 
jprice@stratacuity.com
Code:ClinOps
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.