Job Ref: 212896939

Date: 2020-12-11 17:18:26

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Orion Group Sciences are looking for a Senior Scientist (Pharmacovigilance Scientist II) for our Multinational Pharmaceutical Client based in the Buckinghamshire area on an initial 12-month contract with the potential to extend.

The Sr. 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). The Sr. Scientist 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. The Sr. Scientist will partner with team members, stakeholders including Medical Safety Officers (MSOs), and a vendor.

Main Duties/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/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), 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
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
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
High level of flexibility and ability to (re)prioritize work of oneself 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
This position reports into the Pharmacovigilance Evaluation and Reporting Director, TA Lead or designeeESSENTIAL KNOWLEDGE & SKILLS:

Bachelor's Degree in Health or Biomedical Science (6-8 years industry experience or equivalent)
Advanced Degree Preferred in Health or Biomedical Science (4-6 years industry experience or equivalent)
Clinical/Medical writing or PV experience preferred
Strong English verbal and written communication skills
Scientific Skillset: Working knowledge of applicable global, regional, and local regulatory requirements (eg, ICH guidelines)

For more information on this role, call Denise Cagney on +44 (0) (phone number removed) or email (url removed) for a completely confidential chat about this role and other opportunities using the reference number: (phone number removed)

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment

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