PV Manager Medical Writing - Czech Republic

The position directly reports to the Team lead/Sublead, engages in the technical activities performed within the Primary Unit and works also cross-functional, providing assistance and support with technical activities to other units within the PV department. PV Manager executes project related tasks and activities and is able to delegate activities to other team members within the unit (PV Specialist, PV Associate, PV Assistant) as and if required, and ensures a high quality of the services provided.

What will be your key responsibilities:

Role description:

Provide support with the technical activities performed within the Primary Unit, including Product documentation (SmPC, IB)
Act as lead writer or provide support with the technical activities performed within the Medical Writing Unit, including, but not limited to, scheduling, planning, preparation and QC of development (e.g. DSUR) and post-marketing aggregate reports (e.g. DSUR, PSUR, PBRER, PADER, ACOs etc.), Risk Management Plans (RMP), Pharmacovigilance system master file (PSMF), Pharmacovigilance system master file management
Provide support with the submission of development study aggregate reports, as required
Management of project related PV contracts (PV service agreements, Safety data exchange agreements)
Actively participates in proposal reviews, bid defences, pre-qualification audits, kick-off meetings, and other project-initiation meetings as and if required
Responsible for review and optimisation of their line reports’ utilisation and ensuring agreed targets are achieved

Key responsibilities:

Work on projects and tasks assigned by the unit team lead
Work on other activities as assigned by Associate Director of Technical Areas and/ or Director of Drug Safety according to PV Unit strategy
Manage a group of PV Specialists, PV Associates, PV Assistants within the assigned projects
Ensure the timely delivery of projects/tasks in accordance with client needs as per the contractual agreements and procedures in place

What experience should you have:

Minimum qualifications:

Bachelor’s degree or graduate in pharmaceutical sciences or related fields (medicine, pharmacy, life sciences) – advanced degree (e.g., masters) preferable
Minimum of 4 years of experience working in a medical or safety department with demonstrable expert knowledge of medical terminology or experience working in a medical or safety department to sufficiently demonstrate the knowledge required
Detailed knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.)
Previous experience working in a medical or safety department and demonstrable knowledge of medical terminology
Experience with project management;
Experience working with a safety database
Fluent verbal and written English
Ability to provide training to junior staff
Ability to delegate and oversee work of junior staff
Excellent team player, able to build an effective team
Organizational and time-management skills, able to prioritize work and adhere to deadlines
Excellent communication skills
Maintains a positive, result oriented work environment