Director of Drug Safety Job at Albion Rye Associates, New Jersey

RlFPQmpQSFVxUEh0bStYSVlPNm1DaEVWbkE9PQ==
  • Albion Rye Associates
  • New Jersey

Job Description

Job Title: Director / Snr Director of Drug Safety

Company: Mid-Sized Biotechnology Company

Location: New Jersey On-site

 

Albion Rye Associates are delighted to be exclusively partnering with a dynamic and well-funded mid-sized biotechnology company. With a rich and diverse pipeline, this client is one of the most desirable within the Biotech world across the world to join.

 

We are seeking a Director of Drug Safety to play a pivotal role in ensuring the safety of our investigational and marketed products. Mandarin-speaking capabilities are highly desired to support our global operations, including collaborations in Asia.

 

Key Responsibilities:

  • Strategic Leadership:
  • Develop and implement comprehensive drug safety strategies across the company’s pipeline and marketed products.
  • Serve as the subject matter expert on safety and pharmacovigilance matters in cross-functional teams.
  • Safety Oversight:
  • Lead the collection, evaluation, and reporting of safety data to ensure compliance with global regulations (FDA, EMA, NMPA, etc.).
  • Oversee signal detection, risk assessment, and mitigation activities.
  • Regulatory and Compliance:
  • Ensure compliance with all applicable pharmacovigilance and drug safety regulations, including the preparation of regulatory safety submissions (DSURs, PSURs, RMPs, etc.).
  • Represent the company during interactions with regulatory authorities and external partners.
  • Team Leadership:
  • Build and mentor a high-performing drug safety team to support both development and post-marketing activities.
  • Foster a culture of collaboration and excellence in safety science.
  • Global Collaboration:
  • Partner with global stakeholders, including Asian collaborators, to ensure alignment on safety practices and communication.
  • Utilize Mandarin language skills to facilitate effective communication and understanding in international settings (if applicable).

 

Qualifications:

  • MD, PharmD, PhD, or equivalent advanced degree in a related field.
  • Minimum of 8-10 years of experience in drug safety/pharmacovigilance within the biotechnology or pharmaceutical industry.
  • Proven expertise in global safety regulations and guidelines (FDA, EMA, ICH, NMPA).
  • Strong leadership and strategic thinking capabilities.
  • Exceptional communication and presentation skills.
  • Mandarin fluency (preferred) to support global collaborations and regulatory submissions in Asia.

Job Tags

Permanent employment,

Similar Jobs

TeamHealth

Licensed Clinical Psychologist (15423BR) Job at TeamHealth

TeamHealth has a part-time opportunity for a licensed Clinical Psychologist to join our behavioral health team in Whiteville, North Carolina. While you focus on patient care, TeamHealth supports you by providing you with flexibility and autonomy over your practice. Customize... 

Marathon Petroleum Company LP

Senior scrum master Job at Marathon Petroleum Company LP

 ...environment. Position Summary The Information Technology (IT) Scrum Master (SM) is a key role responsible for ensuring the successful...  ...and pay grade will be based on the selected candidate's experience and qualifications. Key Responsibilities Establishes Agile... 

Mood

Outbound Phone Sales Representative Job at Mood

 ...match! We're on the hunt for passionate and driven Outbound Phone Sales Representatives to join our growing team at Mood. In this role,...  ...we're not your average company. We're a vibrant and innovative online dispensary that features legal cannabis products tailored to set... 

ProMedical Staffing

Ob/Gyn Needed in Indiana Job at ProMedical Staffing

(Physician/MD qualifications required) Obstetrics And Gynecology - OB|Gyn Needed for Group in Indiana Job Description: *Board Eligible or Board Certified Ob|Gyn Needed to join a busy & collegial group *Hospital Employed *Call 1:5*Strong support staff *Some... 

McCarthy Building Companies, Inc.

Carpenter III Job at McCarthy Building Companies, Inc.

 ...level, plumb, area and volume/square concepts~Understand construction terminology~Identify common construction materials,...  ...Safety~Work in an organized manner~Able to work night shifts when needed~Must have reliable transportation to...