Job Overview: Senior Manager, PV will be a key driver of the Company’s commitment towards Pharmacovigilance reporting directly to the Medical Director within Clinical Development
Responsibilities:
Oversight of day-to-day adverse events case management including case intake, tracking and follow-up in accordance with PV procedures, regulations and timelines supported by PV vendors
Contribute to preparation of key Global PV documents, including but not limited to PBRERs, DSURs and RMPs
execution of Global PV processes and activities in collaboration with internal relevant functional areas and external parties
Support to clinical trial aspects related to patient safety
Qualifications:
Master’s degree within Medicine, Pharmacy, Nursing, Epidemiology, Biomedical sciences or equivalent healthcare degree
Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, Minimum of 3 years experience in PV in a global setting preferred
Experience in case management, follow-up and interaction with clinical trial site and prescribing physicians
Experience in contributing to and reviewing aggregate safety reports, safety data, signal detection
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.
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 or
