Country Safety Lead
Do you want to be part of an international, innovative, world-class pharmaceutical company? Of an organization committed to putting patients first? Pfizer has always evolved with the changing needs of the people who rely on us to create a healthier world.
About our role
The Country Safety Lead will have key expertise within Pharmacovigilance and will lead and manage the Drug Safety team with focus on high quality and Regulatory as well as internal compliance. The Country Safety Lead is capable to motivate and to ensure a healthy work-life balance in an often demanding working day. As a people manager the Country Safety Lead will with focus on the individuals and the Team environment on an ongoing basis evaluate need for development and/or initiative to be taken to ensure well-being and ongoing people engagement. The Drug Safety Unit consist of 8 colleagues with a good balance in the experience of team members. Knowledge sharing is an integrated part of the working day, where also humor contribute to successful teamwork. There is room for individualism and cross functional initiatives when needed.
- Lead and manage the pharmacovigilance team of 8 and provide strategic direction.
- Where required by regulations, act as local contact or local QP PV, taking active part and cooperating with the Global QPPV office and being active member of the respective QPPV council.
- Maintain expertise in country as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the country.
- Develop strong partnerships within the country (e.g. Country Managers, Medical, Marketing), and above-country functions.
- Represent Pfizer pharmacovigilance and actively participate in local Pharma Association(s) and other external groups, and effectively communicate to key stakeholders of key issues that could impact PV strategies or the business.
- Accountable for all strategic PV activities for the country
- Serve as point of contact of Pharmacovigilance Business Line for the Pfizer Country Organization.
- Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Pfizer products and to meet regulatory requirements.
- Contact/responsible person in the country, internally and externally, for safety-related aspects and PV.
- Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities.
Education: Degree / Advanced degree in medicine or in life sciences or equivalent experience. E.g. Physician, Pharmacist, Nurse
Work experience: 5+ years within Pharmacovigilance and experience within People management is preferred
- In depth knowledge of national/regional regulatory legislation and guidelines
- Rational approach to issues and their business implications, good problem solving and decision making skills
- Strong interpersonal skills, with a demonstrated ability to manage people and foster teamwork, team building/management
- Excellent communication and negotiation skills - ability to manage discussions
- Ability to meet personal objectives while meeting departmental standards of performance
- Comfortable working in a matrix environment
- Ability to manage/oversee in country and ex-country pharmacovigilance partners
- Knowledgeable in pharmaceutical business, including drug development and regulatory aspects
- Knowledge and understanding of quality aspects, processes, audit and inspections
- Excellent communication in Dutch and English
Company values: Excellence, Equity, Courage & Joy
You will become part of an inspiring corporate culture focusing on people and innovation. Pfizer takes care of you by making sure your working environment, conditions and benefits are good. In addition to the efforts we expect from you, there will room for growth, development and time and attention for relaxation. For example, during the year we organize various sports activities, drinks and voluntary work during working hours / Pfizer4All. You can get in touch with all your other colleagues in a relaxed way.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.