Manager, Pharmacovigilance

We are looking for Manager Pharmacovigilance to join our Pharmacovigilance (PV) team. This is an amazing opportunity to support the team to perform literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.

The Manager Drug Safety Content Analysis will manage and supervise project s PV Operations/training staff on a day-to-day basis, guiding performance of PV Operations staff in ongoing projects in terms of training, quality of deliverables, compliance with the timelines and relevant trainings.

About You - experience, education, skills, and accomplishments

• Master s Degree in life Sciences, Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.).
• A degree in Dentistry/physiotherapy/Nursing, which involves patient exposure in hospital-based environment, would be an advantage
• Around 10 years of experience reviewing biomedical literature for adverse event reporting and atleast 5 years of team management experience
• Excellent leadership and line management skills
• Excellent knowledge of drug safety and the drug development process
• Client focused approach to work
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail
• Ability to train and mentor people

It would be great if you also had the following:

• Certification from a professional medical writer s association
• Experience with commercial and client-specific biomedical literature databases
• Scientific/medical writing background

What will you be doing in this role

• Providing functional expertise/oversight of process and handling queries of the PV Operations staff
• Create
• Participation in meetings with client and within team, as needed.
• Performing activities delegated to the PV Operations staff in case of unplanned peaks or urgent requirements
• Prepare for and respond to internal/external audits/inspections
• Taking suitable action as per client feedback for any performance or process related concerns
• Providing project updates to the Senior Management on periodic basis
• Assisting his/her manager for operational day-to-day activities

About the Team

The PV Literature team supports multiple customers covering all therapeutic areas. It is a supportive working environment with personalized training, and opportunities to engage in different aspects of pharmacovigilance and participate in customer upgrade planning if desired.

Hours of Work

This is a full-time permanent position working weekdays (Monday to Friday)