Job Description Summary
Providing leadership, oversight and expertise with respect to Processes, Procedures (including
Job Description
Major accountabilities:
Oversee process improvements (incl. standardization, simplification), retirements as well as the development
of new processes and procedures (based on business needs, addressing compliance gaps
/ liabilities) across therapeutic areas in Medical Safety
Ensure adherence of Medical Safety processes to regulatory requirements, global safety regulations, and conformity
with PS & PV procedures and processes.
Responsible for having oversight on the Projects within Medical safety involving other PS&PV sub
functions or other GDD line functions
Ensure seamless transition of complex and comprehensive process changes to Projects and support their
successful execution.
Responsible for setting and generating quality metrics for medical review of safety cases, management
of safety signal in the SPOT system, CSR/TPSR review timelines in collaboration with other
sub functions as appropriate
Ensures effective implementation of processes and conventions by Medical Safety colleagues throughout
PS & PV.
Ensure business needs / objectives are adequately addressed by processes and procedures, and thereby, quality
and compliance targets in Medical Safety are met.
Provide expertise, guidance & support for process updates and management of process related issues; this
may include direct support or arrangement of support for the preparation & review of updates of procedural
documents. Support may also include the creation of new processes and procedures
Develop synergies, address issues, and ensure the fulfillment of all Medical Safety responsibilities with respect
to processes owned by functions other than Medical Safety
Identify and assign the right team members / SMEs for new processes and coordinate the SME
participation (
(from Medical Safety) as concerns new or ongoing initiatives impacting on processes with
Medical Safety involvement
If needed/ applicable, interact with Health Authorities globally to address any issues related to Medical
Safety processes, support readiness preparations for PV Audits/Inspections and provide support
during PV Audits/Inspections
Participate at Process Review Board Meetings (if needed) to resolve potential issues related to Medical
Safety processes
Represent Medical Safety in cross-functional and/or cross-departmental initiatives aiming at
improvement of processes
If needed / applicable, act as Process Owner and/or Project Owner (Business Lead) in Medical Safety
and/or Subject Matter Expert representing Medical Safety as concerns process(es) / project(s) owned
by other functions
If needed / applicable, deputize for the Global Head of Medical Safety Operations with respect to
process change affairs / issues
Coach process owners and SMEs in Medical Safety on strategy, scientific as well as process simplification aspects as needed (e.g., organizing training, workshops)
Build & lead a high-performance team and recruit, retain and develop best talents; assess resource needs on a continued basis to meet process excellence objectives and maintain a sustainable compliance culture.
As member of the MSO Leadership Team proactively support defining and executing (if applicable) MSO strategy in alignment with PS&PV strategic priorities.
Key Performance Indicators -
- Establish and successfully maintain ‘Process Excellence’ as institution / platform providing expertise & support, sharing experiences and best practices [Feedback from stakeholders].
- Driving or facilitating process improvements (e.g., standardization, simplification), new processes and/or process retirements [Number of process changes / impact of process changes, e.g., regarding quality of deliverables, process efficiency, compliance].
- Effective & efficient collaboration with other PS&PV functions including PVSO [Feedback from stakeholders].
- No critical findings at Audits / Inspections with respect to Medical Safety processes.
- Adequate implementation / closure on time of Corrective and Preventative Action (CAPA) plans related to Medical Safety processes.
Job Dimensions (Indicate key facts and figures)
Number of associates: Up
to 10 direct & indirect reports
Financial responsibility:
(Budget, Cost, Sales, etc.)
NA
Impact on
the organization: Medical
Safety processes and thereby, fostering compliance and ensuring deliverables of high quality.
Accountable for process developments (changes) in Medical Safety.
Drives change management mindset of compliance throughout Medical Safety.
Exhibits strategic leadership behavior to foster compliance.
Ideal Background (State the required education and experience level)
Education: Advanced degree or equivalent education / degree in Life Sciences / Healthcare. MD, MBBS, PharmD, PhD preferred.
Languages: Fluent in spoken and written English
Experience: Required professional experience:
At least 8 years in drug development in a major pharmaceutical company (of which 5 are in a global position in drug safety / clinical / medical affairs or other relevant line function at an operational or medical position)
Strong leadership and people management skills, with ability to successfully lead, engage and develop a highly effective team.
Excellent negotiation, conflict resolution, decision making, problem solving, communication and presentation skills
Proven ability for clear and concise communication tailored to a diverse audience and effective cross functional collaboration, stakeholder engagement and teamwork
Solid knowledge in drug safety related processes
Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure
Quality oriented
Skills Desired
Clinical Research, Clinical Trials, Functional Teams, Leadership, Medical Strategy, Process Safety Management, Regulatory Compliance, Risk Management, Safety Science