(Senior) Regional IPV Leader EEMEA
(Senior) Regional IPV Leader EEMEA
Switzerland, Basel-Town, Basel
The Senior Regional IPV Leader is there to ensure clarity in the performance of the affiliate PV systems in their assigned countries and to coach the affiliate staff towards achieving the globally set standard. They support the affiliates by helping them assess their PV system and liaising with the global SMEs in case additional support is needed. They escalate concerns in the performance of the affiliate PV systems to the local, regional or global governance levels as appropriate. They ensure the root cause of quality concerns recurring across their region are addressed effectively, with the support of the IPV Process liaison as appropriate. They represent PDS at the Regional Medical Compliance Office and act as the main role to influence the affiliate LSU, LSR, MD, and affiliate GMs in the area of Pharmacovigilance.
The Senior Regional IPV Leader will be in charge of Eastern Europe Middle East and Africa (EEMEA). He/She shall:
- Ensure compliance with regulations and guidelines; escalating issues impacting global PV processes or potentially impacting other affiliates
- Represent PDS for safety activities in interfaces with regional counterparts in the RMCO and Clinical Country Operations, to ensure alignment on issues impacting company PV standards.
- Influence the affiliate GM so that the affiliate PV obligations are known and embedded in the affiliate culture and develop with the affiliates an HA engagement plan to foster proactive policy discussions with local HA
- Establish excellent working relationships with Affiliates to ensure exchange of information enabling a high standard of PV knowledge within the affiliates and an in-depth understanding of what is needed to achieve the highest compliance with global PV guidelines. This includes liaising with functions that interface with the local safety unit, such as regulatory, medical affairs, quality, manufacturing and commercial personnel
- Work with global teams to guide affiliates in developing and implementing local RMPs based on what is feasible/required in the countries and understanding what are the options to measure effectiveness in a given healthcare system.
- Ensure that assigned countries adhere to the Roche PV policies and procedures while new or revisions to existing local reporting requirements for the local health authorities are properly implemented
- Act as the change manager and oversee the implementation of PV processes at local level and leads the content of the regional PV F2F meetings, as appropriate.
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
We are looking for a professional with Medical degree (MD or equivalent) or corresponding professional experience, with minimum 10 years’ clinical research, development, drug safety science or related experience (with a minimum of 3 years’ drug safety or clinical trials’ experience in the pharmaceutical/biotechnology industry) and 5 years minimum in affiliate PV roles or a global role focusing on affiliate support. Further qualification/certification in project management methodologies and/or change management is strongly desired. In addition you bring:
- Significant PV experience in all aspects of PV. Additional experience in regional and/or headquarter roles is desirable and significant experience working with Health Authorities
- Experience in working as part of a large, global cross-functional team. Desirable as team leader for a variety tasks and projects, including team management
- In-depth knowledge of PV, GVP, ICH-GCP and other relevant standards and guidelines
- Well-versed in medical and safety aspects of FDA, EMEA, and other relevant regulations
- Strong project and process management skills: proven abilities to effectively and efficiently manage multiple priorities, goals, objectives and tasks through to successful conclusion
- Strong interpersonal skills: proven abilities to develop important relationships internally and externally, including influencing of key personal in an affiliate
- Strong communication and presentation skills; exhibits professional maturity, confidence, and competence. Knows how to summarize and communicate the key points and business case for others to effectively and expeditiously make important decisions
- Proven expertise with a wide range of data/information: scientific/clinical, safety, legal/regulatory, medical writing, analytics, etc.
Please note that this position requires up to 40% of travelling internationally
Who we are
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more
Roche is an equal opportunity employer.
- Location Switzerland, Basel-Town, Basel
- Function Development
- Subfunction Drug Safety
- Schedule Full-time
- Job level Individual Contributor
- Job type Regular Employee
- Division Roche Pharmaceuticals
- Date 2016/11/14
- Job-ID 3240281330
Get in touch
Cristina Varela+41 61 687 25 27
Work place: Basel or EEMEA Region