Sr. Director/Executive Director PV and Drug Safety 2020394
Location: Waltham, MA (Onsite)
Therapeutic Area: Immuno-Oncology
Job Overview: This role will be responsible for managing drug safety data, authoring safety documents, organizing meetings, collaborating with cross-functional teams, ensuring compliance with global drug safety regulations, and providing vendor oversight.

Primary Job Responsibilities:

• Collaborate with and oversee the work of CROs involved in ICSR management and reporting to business partners.
• Provide subject matter expertise in regulations for case processing and assessment of adverse events.
• Perform quality reviews of draft narratives and analysis reports received from CROs.
• Support signal detection and risk management activities, including the organization of Safety Management Team meetings and preparation of safety documentation

Primary Job Requirements:

• Healthcare professional degree required, with preference given to candidates with early oncology clinical safety experience and biotech industry background.
• 10+ years of experience in drug safety/pharmacovigilance within global clinical trial settings, with expertise in FDA, EU, ICH regulations, and Good Pharmacovigilance Practice guidelines.
• Demonstrated proficiency in drug safety databases (e.g., Argus), electronic data capture systems, and coding with MedDRA and WHO Drug dictionary.
• Strong track record of overseeing global safety activities, managing multiple projects concurrently in a fast-paced environment, and effectively collaborating with cross-functional teams.

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 employeeservices@apexsystems.com or 844-463-6178.