!*Senior Pharmacovigilance - Maidenhead - Global Biotech!*
Location: Fully homebased in the UK
FTE: 12 months (Company average tenure over 4 years. Role will have the view to extend)
Start date: ASAP
Rate: Very good rate
Job Description
Planet Pharma are working with a leading biotechnology company that focuses on neurology, neuropsychiatry, immunology, and rare diseases. It develops innovative medicines to treat complex conditions, including Alzheimer’s disease, multiple sclerosis, and spinal muscular atrophy2. The company is known for its scientific research, drug development, and commitment to advancing healthcare
Objective:
The Senior PV Scientist acts as a product lead for Pharmacovigilance activities within Safety. Responsibilities include overseeing and managing safety signal processes, preparing aggregate reports (PSURs, DSURs, Line Listings, RMPs), addressing safety-related inquiries from internal and external stakeholders, and reviewing medical and scientific literature for safety data.
Additionally, the Senior PV Scientist supports Clinical Trial PV medical activities and serves as a Subject Matter Expert on global safety regulations, data analysis, and product-specific information for cross-functional teams.
Objectives of the mission:
* 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
Requirements:
* 7 or more years of pharmacovigilance experience with pharmaceutical manufacturers.
* Safety surveillance and signal management
* Understanding of GVP
* Experience on systems such as Argus, ARISG etc.
If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
About Planet Pharma
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognized by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.