Senior Specialist, Drug Safety
Senior Specialist, Drug Safety
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description
The Position
The Senior Pharmacovigilance Specialist (Sr PV Specialist) reports to the PV Associate Director and is responsible for the daily case management activities for assigned country(ies).
The PV Senior Specialist is responsible for all PV activities including aggregate and individual case safety report (ICSR) health authority submissions compliance monitoring and may serve as the PV contact with local stakeholders headquarters (HQ) and the local health authority. The PV Senior Specialist collaborates with colleagues to ensure compliance with local laws and regulations including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and safety oversight.
The Sr. Specialist is also responsible for PV activities (as delegated/assigned by their Manager) which may include but are not limited to: PV intake management and negotiation of local PV agreements local due diligence activities participation in audits and inspections and related readiness activities review of local initiatives for compliance with PV requirements SOP management local training communication of safety issues people development and/or special projects and can work on these delegated activities with minimal supervision.
The Sr. Specialist may serve as the deputy/backup Qualified Person for PV (QPPV) / Local PV Contact / Local Responsible PV person as required per local PV legislation. If he/she is nominated to HA as LQPPV any commercial activities which has impact on LQPPV activities are not allowed. In the absence of their Manager he/she is responsible for managing all daytoday activities of the PV department and serves as backup.
Required Education Experience and Skills
- The incumbent must have a health life science or medical science degree or equivalent by education / experience and be fluent in English (written and spoken) while proficient in local language.
- He/she should have a minimum of 7 years of industry experience in pharmacovigilance.
- Advanced Collaboration and Partnering
- Strong communication skill strategic thinking and project management
- Good business operations and knowledge of field
- Deep knowledge of PV regulations and regulatory trends
Secondary Job Description
Must Haves:
7 5 PV
Good to Haves:
PV
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Womens Health expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Employment Type
Full Time
