Senior Pharmacovigilance Scientist (f/m/d) - Post-marketing products

Responsibilities:

• Lead the safety review process and evaluation of safety data throughout the product lifecycle using a combination of quantitative and qualitative approaches, in partnership with the Global Safety Lead (GSL)
• Perform end to end signal detection and analysis activities on safety data sets from various sources, and present summaries of the data in a meaningful way

• Review publications from the scientific and medical literature for important safety information for further use in various analyses or aggregate safety reports (ASRs)

• Provide strategic input and/or contributions to various ASRs (Periodic Safety Update Reports, Development Safety Update Reports, PADERs, Risk Management Plans etc.)

• Organize and provide key insight to internal cross functional Safety Management Teams (SMTs)

• Support product development teams (such as the Study Execution Team and the Clinical Development Teams) with PV related expertise relating to clinical data

• Develop response strategy and perform required analyses for any safety-related questions from internal sources and/or external regulatory requests

• Mentor more junior members of the PVS community, including assisting with on-boarding and providing advice on day-to-day tasks

• Other Activities as required, including but not limited to: case adjudication, review of key clinical documents (IBs, CSRs, etc), support in SOP updates, subject matter expert support for dedicated PVS activities, etc

Qualifications:

• Bachelor’s or equivalent degree (depending on national educational system) required in the pharmaceutical, nursing or biological, or sciences (Degree in Medicine and Pharmacy is preferred)

• At least 3 years’ experience as a Pharmacovigilance scientist or equivalent position in a closely related discipline

• Understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines, and standards.

• Ability to provide solutions for issues/challenges that may arise during the course of a project

• Knowledge and experience of safety monitoring and signal detection preferred.

• Understanding of ICH GCP and drug development preferred

• Computer proficiency in basic database entry and graphics presentations (e.g.,Microsoft Excel or equivalent).

• Excellent written and verbal communication skills in English, with the ability to evaluate, interpret and synthesize scientific data.

• Self-motivated, able to prioritize and plan effectively

• Ability to work independently and as a team player, working in a cross functional environment

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.