Global Product Safety Science Lead — Sobi
NeuCHF 85'500 - 129'500
Sobi · Basel (BS)
- Ort
- Basel
- Vertrag
- full-time
- Veröffentlicht
- Gestern
LohnCHF 85'500 - 129'500
Rollenüberblick
Product-level safety ownership
Perform and lead signal detection, evaluation, validation and escalation activities for assigned product(s).
Set the strategy for safety signal detection methodology, signal tracking and oversight of safety signals for assigned products.
- Product-level safety ownership
- Perform and lead signal detection, evaluation, validation and escalation activities for assigned product(s).
- Provide clinical safety input into study design, conduct, analysis and interpretation, including study‑level Safety Lead responsibilities where applicable.
- Provide medical and pharmacovigilance expertise e.g. for the clinical safety strategy of the product clinical development program, the development of the Target Product Profile (TPP), the development and maintenance of the RSI, including IB and CDS Governance and decision-making
- Drive, perform and document benefit‑risk evaluations and ensure appropriate risk‑management strategies are implemented.
- Translate safety data insights into actionable recommendations for product‑level benefit–risk discussions and regulatory interactions.
Hauptaufgaben
- Provide clinical safety input into study design, conduct, analysis and interpretation, including study‑level Safety Lead responsibilities where applicable.
- Provide medical and pharmacovigilance expertise e.g. for the clinical safety strategy of the product clinical development program, the development of the Target Product Profile (TPP), the development and maintenance of the RSI, including IB and CDS Governance and decision-making
- Serve as the primary decision-maker for product-level safety issues, including signal validation and escalation. Collaboration and delivery
- Lead interactions with external partners and service providers related to assigned product safety deliverables.
- Support regulatory interactions, inspections and audits at product level. People and capability development
- Mentor colleagues and support capability development within the product safety team.
- Continuous improvement & data-driven decision making
- Actively use and continuously develop proficiency in safety systems, data visualization tools, and AI‑enabled analyses (e.g.
- Veeva Vault(s), analytics dashboards) to support robust and efficient signal detection, safety assessments, and decision‑making for assigned products.
- Identify opportunities for process, data and system improvements within Safety Science.
Was das Unternehmen bietet
- Drive, perform and document benefit‑risk evaluations and ensure appropriate risk‑management strategies are implemented.
- Translate safety data insights into actionable recommendations for product‑level benefit–risk discussions and regulatory interactions.
- Chair product‑level Benefit Risk Teams (BRTs) and ensure effective operation per SOPs.
- Represent the BRT at Benefit Risk Council (BRC).
Bewerbungsprozess
- Demonstrated expertise in the understanding, interpretation, and application of various country/regional pharmacovigilance requirements Skills/Knowledge/Languages Required: High quality written and spoken English Strong analytical skills
- Effective communicator (oral, writing, presentations) at all levels of the business
- Ability to work effectively to fulfil ambitious goals
- Sound and balanced judgment skills; able to assess and handle risks; self-confident, proactive and decisive
- Demonstrated ability to lead safety activities and scientific discussions
- Strong team-leadership capabilities.
- Demonstrated relationship builder both internally and externally; a strong collaborator within PV function, leadership and the wider organisation
Weitere Details
- In case of product quality escalations, work cross functionally to understand impacts on patients, and (if required) lead the preparation of a medical impact Health Hazard Assessment statement. Cross-functional execution (MDT)
- Provide medical and pharmacovigilance expertise e.g. for the clinical safety strategy of the product clinical development program, the development of the Target Product Profile (TPP), the development and maintenance of the RSI, including IB and CDS Governance and decision-making
- Serve as the primary decision-maker for product-level safety issues, including signal validation and escalation. Collaboration and delivery
- Support regulatory interactions, inspections and audits at product level. People and capability development
- Education/Learning Experience/Work Experience
- Experience leading cross functional global product safety management teams, successfully delivering medical safety strategy, with experience across safety signal process, aggregate report writing, safety risk communication and safety risk management
- Demonstrated expertise in the understanding, interpretation, and application of various country/regional pharmacovigilance requirements Skills/Knowledge/Languages High quality written and spoken English Strong analytical skills
Notizen und Originalinhalt
- In case of product quality escalations, work cross functionally to understand impacts on patients, and (if required) lead the preparation of a medical impact Health Hazard Assessment statement.
- Cross-functional execution (MDT)
- Provide medical and pharmacovigilance expertise e.g. for the clinical safety strategy of the product clinical development program, the development of the Target Product Profile (TPP), the development and maintenance of the RSI, including IB and CDS
- Governance and decision-making
- Serve as the primary decision-maker for product-level safety issues, including signal validation and escalation.
- Collaboration and delivery
- Support regulatory interactions, inspections and audits at product level.
- People and capability development
- Demonstrated expertise in the understanding, interpretation, and application of various country/regional pharmacovigilance requirements
- Skills/Knowledge/Languages
