Job Description
Job#: 2041212
Job Description:
PV Operations Manager, Drug Safety & Pharmacovigilance 2041212
Location: Cambridge MA (Hybrid)
Therapeutic Area : Rare Disease
Job Overview: The PV Operations Manager will oversee ICSR case processing, medical review, and safety database management in clinical trials, requiring project management and communication skills in a dynamic environment.
Primary Job Responsibilities:
- Oversee ICSR medical review strategies in collaboration with cross-functional teams
- Manage the safety database with PV vendor oversight
- Represent DSPV in key cross-functional team meeting
- Guide vendor interactions and streamline Safety Management Plan implementation
Primary Job Requirements: - Experienced safety professional (RN, PharmD) with at least 7+ years in drug safety, pharmacovigilance, and clinical experience from direct patient care
- Hands-on experience with good pharmacovigilance practices and international regulatory requirements (EMA/FDA/ICH) for ICSR case processing, medical review, and regulatory submissions
- Proficient with MedDRA dictionary, strong case processing, and narrative writing skills
- Experienced in using software-based drug safety systems (e.g., ARGUS, ARISg) and proficient in MS Office
- Prior experience with gene therapy products or biologics
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.
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 .
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
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- Dice Id: apexsan
- Position Id: BHJOB2374_2041212
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