Responsibilities

Position Summary

The scientist will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, standard complexity). He/She will have in- depth product knowledge and will support Safety Management Team (SMT) deliverables as required. Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents. He/She will partner with team members, stakeholders including Medical Safety Officers (MSOs), and a vendor.

Primary Responsibilities:

• Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate
• Collaborate with Therapeutic Area Safety Head (TASH), MSO, Safety Surveillance Physician (SSP) 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, and coordinate the preparation of core safety deliverables
• Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs) and assessment reports) are met
• Partner with vendor to develop reports/deliverables
• Provide SMT support as needed
• Act as ad hoc member for assigned products as appropriate
• Recognize potential issues and or safety issues and escalate to the attention of the report owner, line manager, or MSO
• Ability to understand nature of adverse drug reactions and complex associations
• Maintains a high level of flexibility and ability to reprioritize ones work and others
• Attention to detail and ability to analyze data in broader context
• Ability to work across multiple functions and therapeutic areas
• Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance

Training/Meetings/Department Initiatives:

• Participate in cross-functional training of relevant stakeholders
• Attend departmental meetings and trainings
• Participate in department and/or cross-functional initiatives

Secondary Responsibilities:

• Safety Management Teams (SMT) for assigned products - Lead SMT meeting. Lead and drive discussions and formulate decisions along with core members
• Risk management plans - Provide guidance on RMP creation and updates. Reviews and align approvals with oversight leads of the Risk Management plan
• Periodic Benefit Risk Evaluation Report (PBRER)/ Periodic Safety Update Report (PSUR) - Reviews and align approvals with lead oversight. Leads strategy of the PBRER process.
• Health authority queries -Work with MSO, scientist to organize data, review cases, literature, write Marketing Authorization Holder (MAH) comments
• Participating Affiliate Core Data Sheets (CCDS), US and EU prescribing information updates - Form part of the label working group and provide guidance related to the label updates.
• Signal Validation and Evaluations - Work with Scientist to review preliminary data to determine if the signal is valid and would require further evaluation. Lead and drive the signal evaluation process
• IB updates for safety sections - Evaluate clinical data for ADRs, assist with section 5 and Reference Standard Information (RSI) tables as needed
• DSURs - Reviews and aligns Safety approvals with lead oversight.
• Addendum to Clinical Overviews - Provide support with review, and characterization of risks, data review
• Literature reviews for class effects and ad hoc reports -Review articles and create MAH Comments for assessment of the articles
• Product Safety Strategy (PSS) - Review the risks documented in the PSS and oversee the updates as necessary. Align approval of the PSS updates with oversight.
• Handing Level 2 Escalations/HHE - Participate in level 2 escalations and assess whether there is a Safety impact and an HHE is needed. Lead and drive the HHE process.
• Clinical Development Team (CDT), Local Working Group (LWG) and other cross functional meeting participation - Participate and provide safety inputs as required

Minimum Qualifications

Education/Experience:

• Bachelor’s degree in Health or Biomedical Science and six to eight years of industry experience or equivalent, or Advanced degree (preferred) in Health or Biomedical Science and four to six years of industry experience or equivalent)
• Physician (MD or equivalent) generally requires 2-5 years of pharmacovigilance experience or other relevant experience (e.g., Clinical research, Medical Affairs). Demonstrated skills in clinical medicine with at least 3 years of clinical practice experience is preferred.
• Clinical/medical writing or pharmacovigilance experience preferred
• Strong English verbal and written communication skills.
• Demonstrated knowledge of principles of drug development, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development as well as global safety regulations, is highly preferred.