Medical Director/Sr. Medical Director, PV
Medical Director/Sr. Medical Director, Pharmacovigilance 1326481
Location: Waltham, MA (Remote or Hybrid)
Science: Antibody Drug Conjugates
Therapeutic Area: Oncology
Job Overview: The Medical Director will play a pivotal role within the pharmacovigilance team to develop and maintain safety assessments for all company products.
Responsibilities:
- Establish, enhance, and implement robust surveillance and benefit-risk processes based on clinical, scientific, and pharmacovigilance expertise to provide strategic support for products across lifecycle
- Establish risk management process starting early in development of company product(s). Work with clinical teams to develop risk management plans to support regulatory submissions
- Oversee signal management and risk management activities of assigned company products on a global basis across the life cycle, starting with early development
- Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities
Qualifications:
- M.D. degree or equivalent with a minimum of 5-7 years of experience in PV organizations in the pharmaceutical/biotechnology industry is required. Oncology experience will be a significant advantage
- Previous experience as lead safety physician for clinical trials and marketed products
- Experience in signal detection with demonstrated experience in analysis, and interpretation of medical and scientific data.
- Experience in safety data analysis and writing study related aggregate reports and safety assessments.
- New product launch experience desired
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.
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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 employeeservices@apexsystems.com or 844-463-6178.