Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist)

Xenon Pharmaceuticals•Needham, MA

1d•$222,600 - $317,600•Hybrid

About The Position

We are seeking a Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist) to join our Pharmacovigilance and Safety team. The successful candidate is responsible for safety surveillance and development of aggregate safety reports in compliance with global drug safety regulations and departmental procedures. As such, the role is part of a team that performs high quality and timely scientific analysis of safety data, applies critical thinking skills and synthesizes data findings into clear, concise, and evidence-based statements. The successful candidate will be collaborating with safety physicians and risk management team to perform safety surveillance activities through proactive signal detection, ongoing benefit-risk analyses, and safety monitoring/reporting activities for all Xenon’s clinical assets and future marketed products. The successful candidate will author safety documents, reviews safety sections of other documents, for Xenon products throughout the product lifecycle from First-in-Human (FIH) to post-marketing, performs QC, and, when necessary, assists in responding to information requests from Health Authorities for Xenon products, participate in cross-functional Safety Risk Management Team (SRMT) meetings and collaborate with colleagues in Clinical Development, Trial Operations, Clinical Pharmacology, Biostatistics & Programming, Regulatory, Medical Affairs, non-clinical safety lead, QA and Legal departments. This position reports to the Executive Director, Pharmacovigilance and Drug Safety, and will be based out of Boston, MA, USA in our Needham office. We may consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. For Boston-based candidates, this is a Hybrid position requiring a minimum of two onsite days per week.

Requirements

Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 9+ years (Dir)/12+ (Senior Dir) of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments.
Director will have a minimum of bachelor’s degree with a minimum of 10+ years management experience in a pharma or biotech environment; Master’s degree preferred.
Senior Director will have a minimum of Master’s degree with a minimum of 8+ years management experience in a pharma or biotech environment.
Ability to lead cross-functional team through all activities in the full clinical study life cycle.
A good understanding of all phases of the drug development process between DSPV, Clinical, Regulatory Affairs, and other functional areas. Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities.
Experience leading and authoring safety signal assessment report, DSUR, PADER, PBRER, and contributing to safety and risk management sections of other regulatory safety reports (RMP, RSIs).
Skilled in signal detection process and managing safety information from clinical development and post-marketing sources.
Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management.
Knowledge of drug development process, pharmacovigilance databases and MedDRA coding.
Understanding of clinical disease state and implications of treatment.
At ease with data handling and visualization, statistics, and technical writing skills.
Experience with use of safety databases, preferably Argus Safety Database and signal detection tools.
Strategic critical thinking skills with focus on data integrity and high-quality outputs.
Excellent verbal and written communication skills with ability to communicate effectively by writing clearly and concisely, and strong presentation skills.
Time management skills with ability to prioritize to meet required deadlines.
Ability to multitask and prioritize under tight deadlines while providing attention to detail and high-quality work in a dynamic environment.
Ability to be flexible, adapt to change, work independently, as well as experience working in a highly collaborative matrix environment.
Ability to work both independently and as part of a multidisciplinary team that is results-oriented.
Strong interpersonal skills and ability to foster strong collaborative relationships with internal and external team members.

Responsibilities

Lead the proactive signal detection activities, support the ongoing benefit-risk analyses, and safety monitoring/reporting activities for Xenon products across all stages of development.
Lead and manage Aggregate Safety Reports (e.g., IND/NDA Annual Reports, PADER, DSUR, PSUR, PBRER, ad-hoc regulatory responses, etc.) for Xenon products throughout product lifecycle from FIH to post-marketing in compliance with global safety regulations and guidelines and provide training within DSPV and cross-functionally.
Author Aggregate Safety Reports while working in collaboration with the cross functional teams (i.e. Non-clinical, Clinical Development, Trial Operations, Regulatory, Biostatistics, and Clinical Data Management) to compile safety information.
Support and review safety-related documents for Xenon products throughout product lifecycle from FIH to post-marketing such as Safety Assessment Reports, product labeling, risk management/risk mitigation-related documents, and responses to ad-hoc information requests by Health Authorities and internal stakeholders.
Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and support safety team to develop safety related responses.
Maintain continuous monitoring/updating of safety profiles for assigned investigational and marketed products. Collaborates with physicians and risk management team in ongoing risk/benefit assessment.
Performs careful review of all serious events of interests and expedited individual case safety reports ensuring that the knowledge gained from these individual reports contribute to a higher degree of interpretation, consistency, and quality of the analysis at the aggregate level. Reviews and provides input to Analysis of Similar Events (AoSE), as needed.
Review and communicate trending, signaling, and other safety-related issues originating from any source for the purposes of detecting and reviewing safety signals (e.g., change in frequency, nature, or severity of a safety-related issue) in a timely manner.
Participates and contributes to cross-functional SRMT meetings for signal management, risk management detection, and benefit-risk assessment for Xenon products.
Review potential issues and safety signals and contribute to the SRMT and Safety Governance process through the preparation and presentation of safety data; prepare and assess safety data for ongoing periodic / aggregate safety data review.
Author the safety signal assessment reports in collaboration with Safety Physicians.
Support the risk management team in the development of risk management strategies and activities.
Review SMP and provide input to safety related sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), SAPs, DSMB charters, and other relevant documents.
Write and maintain relevant SOPs and procedures in compliance with global regulations and guidelines.
Support inspections by participating in audit preparedness activities and providing requested information.
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
Other duties as assigned.