Senior Scientist, Risk Management & Safety Surveillance

ClinChoice

7d•Remote

About The Position

ClinChoice is seeking a Senior Scientist, Risk Management & Safety Surveillance to join its in-house team on a permanent basis. The scientist is responsible for core safety deliverables, including scheduled and ad hoc aggregate reports, and serves as report owner for assigned medium-to-large-volume reports of standard complexity. The role requires in-depth product knowledge and support for Safety Management Team (SMT) deliverables. Daily work includes planning and conducting meetings, searching databases, performing aggregate safety analyses and case-level reviews, writing, and coordinating strategic safety documents. The scientist partners with team members, stakeholders such as Medical Safety Officers (MSOs), and a vendor. The role also supports broader product safety activities, including SMT leadership, risk management plans, periodic benefit-risk and safety reports, health authority queries, labeling updates, signal evaluation, safety sections of investigator brochures, development safety update reports, literature reviews, product safety strategy, escalations, and cross-functional meetings. The scientist may provide guidance and review with oversight from leads, and is expected to identify and escalate potential safety issues, manage changing priorities, and work across functions and therapeutic areas. ClinChoice is a global full-service CRO serving pharmaceutical, biotechnology, medical device, and consumer health companies. It reports more than 28 years of experience and over 4,000 professionals in more than 20 countries. The company describes a quality-focused, collaborative “one-team” culture, emphasizing employee development, continuous training, diversity, and inclusion.

Requirements

Bachelor’s degree in Health or Biomedical Science and six to eight years of industry experience or equivalent; alternatively, an advanced degree in Health or Biomedical Science and four to six years of industry experience or equivalent.
For physicians (MD or equivalent), generally two to five years of pharmacovigilance or other relevant experience, such as clinical research or Medical Affairs.
Strong English verbal and written communication skills.
Ability to understand adverse drug reactions and complex associations, analyze data in broader context, and attend to detail.
Flexibility to reprioritize work and ability to work across multiple functions and therapeutic areas.

Nice To Haves

Advanced degree in Health or Biomedical Science is preferred.
Clinical or medical writing or pharmacovigilance experience is preferred.
Knowledge of drug development principles, assessment of drug risks and benefits, safety assessment of marketed and investigational drugs, and global safety regulations is highly preferred.
For physicians, at least three years of clinical practice experience is preferred.

Responsibilities

Ensure timely, high-quality reports and safety analyses for core deliverables, with oversight as appropriate.
Collaborate with the Therapeutic Area Safety Head, MSO, Safety Surveillance Physician, and other stakeholders on strategy development.
Initiate, conduct, and oversee searches of internal and external databases.
Perform and/or lead aggregate safety analysis and case-level review.
Author, contribute to, and coordinate core safety deliverables.
Ensure commitments, including Pharmacovigilance Agreements and assessment reports, are met.
Partner with vendors to develop reports and deliverables.
Provide Safety Management Team support as needed and act as an ad hoc member for assigned products.
Recognize and escalate potential issues and safety concerns to the report owner, line manager, or MSO.
Participate in cross-functional training, departmental meetings and training, and departmental or cross-functional initiatives.
Lead SMT meetings for assigned products, drive discussions, and formulate decisions with core members.
Guide creation and updates of risk management plans and review plans for alignment and approval with oversight leads.
Review PBRER/PSURs, align approvals with lead oversight, and lead the PBRER process strategy.
Work with MSOs and scientists on health authority queries by organizing data, reviewing cases and literature, and writing MAH comments.
Participate in label working groups and provide guidance on CCDS and US and EU prescribing information updates.
Review preliminary data for signal validation and lead and drive signal evaluations.
Evaluate clinical data for adverse drug reactions and assist with investigator brochure safety sections and RSI tables as needed.
Review DSURs and align safety approvals with lead oversight.
Support addenda to clinical overviews through review, risk characterization, and data review.
Review literature on class effects and prepare MAH comments for article assessments.
Review risks documented in Product Safety Strategy and oversee updates and approval alignment with oversight.
Participate in Level 2 escalations and assess safety impact and the need for an HHE; lead and drive the HHE process.
Participate in Clinical Development Team, Local Working Group, and other cross-functional meetings and provide safety input as required.
Understand the nature of adverse drug reactions and complex associations; analyze data in broader context and reprioritize work as needed.
Review regulatory assessor comments and requests and address them as appropriate with guidance.