Drug Safety Surveillance Manager

Summary:

My client is an innovative pharmaceutical company that are looking for a Safety Surveillance Manager to lead safety risk management activities including; signal evaluation and management, update and maintenance of core safety documents, aggregate report production and general PV support to clinical development and post-marketing surveillance.

Responsibilities:

• Compile data and review of safety data for signal detection/management activities
• Oversee the maintenance and production of aggregate safety reports
• Provide PV input into other regulatory documents or dossiers as required
• Support the safety evaluation team to ensure all activities are carried out and recorded appropriately
• Provide mentoring and training to newer PV team members, when required
• Lead ongoing scheduled and ad-hoc safety signal detection activities as required
• Manage detected signals through the evaluation process
• Evaluate safety data for presentation at the Corporate Safety Board
• Create and maintain aggregate safety reports
• Support NDA / IND / MAA / CTA activities
• Other medical writing or risk management activities
• Respond to safety related queries from internal and external partners including Regulators
• Execute additional tasks in order to meet departmental project-related or developmental / change objectives

Requirements:

• Sciences degree
• Demonstrable experience in safety evaluation and risk management in the clinical development and/or post-marketing setting gained in pharmaceutical industry
• Ability to lead the evaluation and resolution of safety issues with cross-functional teams
• Good operating knowledge of pharmacovigilance databases
• Proficiency with safety databases and safety coding dictionaries
• Detail-oriented, with good organizational, communication, and time management skills
• Strong leadership and people management experience
• Excellent communication and collaboration skills with the ability to present to internal/external groups and establish and maintain good working relationships at all levels

To apply 
If you would like to discuss this vacancy further or to discuss your career options in confidence, please call Tiffany Gardner on 02039288385 or email: tgardner@planet-pharma.co.uk

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 recognised 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.

www.planet-pharma.com