Director, Pharmacovigilance 2025263
Location: Boston, MA (Hybrid)
Science: Small Molecule
Therapeutic Area: Rare Disease
Job Overview: This director will lead and oversee safety and benefit-risk management for assigned products, working closely with the Global Safety Physician and Medical Risk Management team, serving as a subject matter expert on product safety information and global safety regulations.
Primary Job Responsibilities:

• Oversee signal detection and management for assigned products, evaluating ongoing safety data and signals.
• Coordinate and present at safety governance meetings to ensure effective safety management for assigned product(s).
• Organize the filing and maintenance of GVP documentation for appropriate GXP recordkeeping activities and responsibilities relating to assigned product(s).
• Author or oversee the preparation of aggregate reports (DSUR, PBRER, PADER, etc.) for assigned product(s).

• Medical Degree, Pharmacy degree, Nursing degree (BS, MS), or MS in a health-related field.
• Minimum 10 years of experience in biotech/pharmaceutical industry, with at least 8+ years as a PV Scientist or similar role, preferred experience in Gastrointestinal therapeutic or rare disease area
• Experience with MedDRA coding, safety databases, and clinical trial databases.
• Demonstrated experience leading the development, authorship, and review of aggregate reports and key safety-related documents (e.g., DSUR, IND annual report, PBRER, PADER, RMPs, REMS).
• Strong knowledge of global post-marketing and clinical trial safety regulations, guidance, and reporting processes, experience with a post-marketed product undergoing clinical development is a plus.

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.