Pharmacovigilance Manager

Job content

Senior Pharmacovigilance Scientist 100%

Description:

Senior PV Scientist serves as a global product lead for Pharmacovigilance activities within Safety. The Senior PV Scientist is responsible for overseeing and leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings, RMPs), responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities. The Senior PV Scientist, along with the Associate Director is responsible for hiring, training, mentoring and managing staff within their assigned products. The Senior PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information. In this capacity, the Sr. PV Scientist is critical to ensure products in clinical trials continue to maintain good standing with countries where studies are ongoing to ensure clinical studies are completed, and for marketed products, ensures the marketing authorization remains in good standing.

Responsabilities

• Leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.

• Leads process for responding to safety questions from regulatory authorities.

• Leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).

• Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.

Company profile

Within the Pharmaceutical Industry globally & successfully operating company.

Place of work

Baar

Start of work

February 2022

Languages

Fluent in English

Education

Bachelor’s Degree in biologic or natural science; or health case disciplineAdvanced degree (PhD, MPH, NP, PharmD, etc.) required

Experience

Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.

Motivation

A dynamic working environment focusing on career opportunities where multi-cultural teams from all over the world strive the best results.

Special requirements

Please mention the job Number (BIOBJP00003560) in your application. You can also send your application to: i.vlas@universal-job.ch