Pharmacovigilance Associate II

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

• This role supports the aggregate reports preparation process, by generating and collecting required data to support writers in report preparation along with authoring relevant sections of the assigned reports. This role also supports the aggregate reports preparation process providing QC.

• Generate required reports (line listings, summary tabulations) from PV database and BI platforms for all assigned reports).
• Collecting/assimilating data to support writers in report preparation along with authoring relevant sections for all assigned reports.
• Ensure the cases within the PV database is complete with accurate information in all data fields required for preparation of the reports by promptly raising correction requests to relevant teams and following up until resolution in line with applicable control procedural documents.
• Assess and perform case separation per formulation/dose/dosage/indication as applicable prior to report generation using BI platform.
• Review/ perform QC of the data generation, collection and authoring for assigned reports.
• Act as topic lead for selected parts of the process/projects.
• Coach, develop and mentor junior staff within the team.
• Drafting responses to queries from stakeholders and requests from regulatory agencies, as required.
• Author and maintain training documents/working procedures under the scope of the team.
• Making sure assigned periodic reports support activities are performed in line with all applicable working procedures.
• Collaborative working relationships with peers, writers and other functions within organization unit and in Teva.
• Any other task assigned by direct manager.

• University degree [BDS, BAMS, BHMS, Pharm.D, M.Pharm (Pharmacy Practice/ Pharmacology/Regulatory affairs)] 
• 2-3 years of experience in Pharmacovigilance (Medical writing and/or ICSR/case processing including clinical trials). Previous experience in preparation of periodic reports is desirable.
   

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.