Senior Manager - Compliance and Drug Safety and Pharmacovigilance Operations 2032348 Job at Stratacuity: Proven Scientific Placement, Cambridge, MA

OEQ4ekNWV3FBWkczZW9VbmdnYVNpeWs0N1E9PQ==
  • Stratacuity: Proven Scientific Placement
  • Cambridge, MA

Job Description

Location: Cambridge, MA (Hybrid)

Science: Small Molecule

Job Overview: This role will ensure PV compliance and operational excellence, partner across teams to uphold safety and regulatory standards, and support the PV Quality system under the Senior Director's guidance.

Primary Job Responsibilities:

· Manages PV Quality System and ensures compliance with inspection standards.

· Provides expertise in safety operations and leads PV metrics development.

· Collaborates on document creation and safety protocols with stakeholders.

· Oversees training, vendor relations, and readiness for inspections and compliance.

Primary Job Requirements:

· Bachelor's in nursing, pharmacy, or life sciences required; Master's or Doctorate preferred.

· Over 5 years in Drug Safety/Pharmacovigilance with a focus on PV Compliance.

· 3-5 years' experience in CRO and vendor management.

· Familiar with GCP/GVP regulations and experienced in regulatory inspections.

· Strong understanding of regulatory standards, with excellent analytical and communication skills.

· Skilled in promoting teamwork and navigating challenges.

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. 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.

Job Tags

Similar Jobs

R K Mehrotra - State Farm Agency

Licensed Insurance Sales Representative Job at R K Mehrotra - State Farm Agency

 ...Licensed Insurance Sales Representative Location: BATON ROUGE, LA, 70806 Salary: $5...  ... Paid Holidays and Paid Time Off Health Insurance Retirement Plan Professional...  ...with a State Farm independent contractor agent, not with State Farm Insurance Companies.... 

Experic

Production Operator Job at Experic

 ...JOB DESCRIPTION Position: Production Operator Department: Operations Reports To:...  ...Experic including Regulatory, Safety, SOPs, Work Instructions, etc. Assist in the...  ...complex rules to specific problems to produce answers that make sense. Inductive Reasoning:... 

US Tech Solutions

Technical Writer- Cyber & Physical Security Job at US Tech Solutions

 ...Duration: 24 Months Contract (Hybrid) As a technical writer focused on Cyber and Physical Security you will analyze, review, and research current business practices and industry benchmarks to create easily accessible internal policies, procedures, and assorted documentation... 

Fenergo

Marketing Manager - Americas Job at Fenergo

 ...development and execution of marketing plans that align with the America regions goals across segments and motions, ensuring demand...  ...calendar of events and roundtables that nourish different segments banking, asset management, asset servicing etc. ~ Coordinateand... 

Gpac

Steel Detailing Project Manager Job at Gpac

Miscellaneous Metals Manager: GPAC is partnered with a well-established steel fabricator to hire a Steel Detailer that has experience as a Project Manager to run the miscellaneous metals department. Due to an increasing work load the company needs to hire an experienced...