Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
PV Case Management Specialist (12 month contract)
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Sr PV Case Management Specialist, are to:
- The PV Case Management Specialist (CMS) is a key individual trained in the PV safety databases (ARGUS), PV case processing systems, working with Central PV, PV procedures and tools including the timely submission of reportable cases and MDPRs to Health Canada.
- This role reports to the PV Case Management Manager and is a member of the Canadian PV Case Management Team.
- The role helps to ensure full compliance with Health Canada requirements as well as compliance with other Health Authorities in countries where Bayer Products are marketed.
- Accountable for ensuring pharmaceutical and medical device cases are performed with the highest quality standards of both Bayer PV and Health Canada and are submitted to Health Canada in a timely manner.
- This accountability includes but is not limited to:
- Expedited reporting of ICSRs, including MDPRs to Health Canada in accordance with Bayer Standard Operating Procedures and Health Canada regulations.
- Performs follow-up requests and contacts reporters as appropriate to obtain missing case information and/or additional clarifications.
- Performs periodic reconciliation between the Bayer safety database and the HC ADR online database.
- Ensures timely and regular Argus data retrieval for the purposes of spot QC, reconciliation and the collection of other key performance indicators (KPls) for process improvement.
- Ensures that all required follow-up attempts for assigned cases have been completed.
WHO YOU ARE
Your success will be driven by your demonstrations of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possess the following:
- Education: BSc., nursing, pharmacist or other life science university degree. Health Care Practitioner preferred
- A minimum of 2 years' experience in a (global) healthcare organization, esp. Clinical Development and/or Medical Affairs and/or Pharmacovigilance
- A minimum of 2 years' experience in the pharmaceutical PV environment including experience in Argus
- Highly effective communicator
- Strong organizational and process management skills
- Ability to take personal responsibility and accountability
- Experience of working across functions and building effective working relationships between functions and with external customers
- Fluency in English (written and verbal communication skills)
- Collaborative, team-oriented, resilient
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 174304
Functional Area: Medical Affairs & Pharmacovigilance