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.
- 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.
Cross-functional execution (MDT)
- 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.
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.
Level of autonomy: works independently with accountability for assigned products, escalating complex or cross‑product issues as appropriate.
Education/Learning Experience/Work Experience
Required:
- MD, PharmD, PhD or Master’s in Life Sciences/Public Health
- Solid experience in pharmacovigilance and safety science within a pharmaceutical or regulatory environment
- Strong knowledge of global PV regulations (e.g., GVP, ICH E2E), pharmacovigilance processes and practices
- Proficiency to analyse, synthesize medical & scientific safety data and contribute to scientific interpretation
- Strong communication & stakeholder collaboration skills
- Proficiency in Excel, database querying (e.g., SQL), and basic data visualization (e.g., Power BI, Spotfire), AI-related tools
- Experience working with development programs and with products with market approvals
- 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
Desired:
- Experience working with partner companies to successfully develop and market products across global markets
- Experience presenting medical safety information at Health Authority meetings
- 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