Responsibilities
- 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.
- Drive, perform and document benefit–risk evaluations and ensure appropriate risk-management strategies are implemented.
- Lead and perform assessments for the preparation, review and approval of key safety deliverables (e.g. PSURs, DSURs, RMPs, regulatory responses).
- Translate safety data insights into actionable recommendations for product-level benefit–risk discussions and regulatory interactions.
- Lead the clinical safety science interactions with partner companies for the assigned products (if applicable) ensuring sharing of safety information per the SDEA and the set up and collaborative functioning of the JSMT.
- Provide safety scientific input to ISS Evaluation Committee as required.
- 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.
- Act as the Safety Science representative in the Medical Development Team (MDT) and ensure integration of safety into product development and lifecycle decisions.
- 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.
- Chair product-level Benefit Risk Teams (BRTs) and ensure effective operation per SOPs.
- Represent the BRT at Benefit Risk Council (BRC).
- Serve as the primary decision-maker for product-level safety issues, including signal validation and escalation.
- Lead interactions with external partners and service providers related to assigned product safety deliverables.
- Support regulatory interactions, inspections and audits at product level.
- Mentor colleagues and support capability development within the product safety team.
- 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.
Requirements
- Responsible for performing and leading safety surveillance and benefit–risk activities for one or more assigned products across the product lifecycle.
- Represents the primary product-level safety owner.
- Drives safety strategy implementation in collaboration with other colleagues within Safety Science.
- Chairs benefit–risk discussions and ensures high-quality safety deliverables within cross-functional product teams.
- Ensures that safety considerations are fully integrated into development and lifecycle decisions, in compliance with GVP, GCP and global regulatory requirements.
- Works collaboratively with other members of the Sobi Global Pharmacovigilance team, and other internal functions across Sobi or externally.
Work Arrangement
Remote (City/Region) — Stockholm, Basel
Additional Information
- The role combines scientific leadership and hands-on execution.
- The GPSSL works collaboratively with other members of the Sobi Global Pharmacovigilance team, and other internal functions across Sobi or externally.
- Level of autonomy: works independently with accountability for assigned products, escalating complex or cross-product issues as appropriate.
