Director Safety Surveillance Us - Deerfield, United States - Lundbeck

Lundbeck

Verified Company

Deerfield, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best.

Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth

SUMMARY:

The Director, Safety Surveillance US will provide strategic leadership to the Safety Scientists to execute on PM safety surveillance activities in the US working directly with safety assessment teams, including the Safety Leads, and other US R&D teams.

The incumbent will maintain oversight of safety related post approval commitments, risk minimization activities and any mandated REMS programs throughout the life cycle of Lundbeck products.

This individual provides strategic direction for analyzing aggregate safety data and communicating potential changes to benefit-risk balance to GPS and R&D Management as well as to external stakeholders and customers.

ESSENTIAL FUNCTIONS:

Leads the safety surveillance activities for products assigned to the Global Medical Safety-US organization including the preparation/submission of IND and NDA related aggregate reports (IND Annual, DSUR, NDA Annual, PSUR, PBRER, RAR).
Maintains oversight of signal detection, risk management activities and REMS programs.
Ensures that signal and benefitrisk assessments for Lundbeck products are performed in a timely manner and any changes to the safety profile and benefitrisk balance are appropriately communicated internally to GPS and R&D Management, as well as to external stakeholders and customers.
Provides strategic direction to the Safety Scientists and leads the review of the overall benefit/risk profile of marketed products and compounds in development at specified intervals according to regulatory requirements and SOPs.
Participates in direct verbal and written communication with Regulatory Agencies on safety signals and health hazard evaluations, as required by company SOPs.
Provides management oversight to the Safety Scientists in performing a robust medically scientific evaluation of safety signals and ensures accurate documentation.
Works crossfunctionally to support labeling review and proposed labeling changes resulting from recommendations by the Safety Committee to the Safety Board.
Designated lead on behalf of GPS-US as SME for risk management and aggregate reports during all inspection activities from regulatory agencies as well as internal audits by R&D Quality
Maintains oversight of strategic US PM safety surveillance projects within GPS in line with GPS and Global Medical Safety strategies
Identifies potential gaps and leads process optimization and implementation of new processes/procedures across GPS to ensure that the business has appropriate safety surveillance processes and systems in place in compliance with regulatory requirements.
Member of GPS US Management team, responsible for coaching and managing staffing needs; budget ownership of cost center, and setting strategies for the recruitment, hiring, mentoring and development of staff.

REQUIRED EDUCATION, EXPERIENCE, and SKILLS:

Accredited BS/BA in health sciences.
10+ years of experience in a pharmaceutical company or the equivalent experience in a healthcare setting judged to be sufficiently related.
5+ years of drug safety/pharmacovigilance experience or in an environment with a function similar to that of Pharmacovigilance.
3+ years of experience with data analysis, aggregate reporting, and REMS/risk management practices.
Solid experience with analyses of Big Data, good understanding of methodologies and leveraging realworld data to support and enhance PV activities.
Excellent working knowledge of local and global regulations/guidelines in pharmacovigilance and risk management, REMS programs.
Advanced ability to develop aggregate data and interpret, analyze, and summarize information for meaningful assessment.
Experience in liaising with regulatory agencies regarding pharmacovigilance matters.
Able to manage both timely and multiple priorities simultaneously.
Excellent organization and interpersonal skills, both written and verbal.

PREFERRED EDUCATION, EXPERIENCE, and SKILLS:

Doctorate or Accredited Master's degree in health sciences, epidemiology, or public health.
Global pharmacovigilance experience supporting EU or Asia
Pre and post market surveillance experience

TRAVEL:

Willingness/Ability to travel up to 5% domestically. International travel may be required.
For remote hires, local presence required in the Deerfield, IL office 12 times a month.

Why Lundbeck
Lundbeck offers a robust and comprehensive benefits package to help