Job Description

We are looking for Senior Manager Drug Safety Content Analysis to join our Pharmacovigilance (PV) team (offices working in Hybrid model). 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 Senior Manager Drug Safety Content Analysis will manage and supervise project\xe2\x80\x99s AMs/ Managers and project\xe2\x80\x99s PV Operations staff on a day-to-day basis, guiding performance of PV Operations staff in ongoing projects in terms of quality of deliverables, compliance with the timelines and relevant trainings. He/she will also provide process-related expertise for the various project specific activities ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs) and communicate with client for queries/feedback.

About You \xe2\x80\x93 experience, education, skills, and accomplishments

• Master\xe2\x80\x99s 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 in Pharmacovigilance and atleast 6+ years of team management/project management experience
• Excellent leadership and line management skills
• Excellent knowledge of drug safety and the drug development process
• Excellent knowledge and ability to interpret and apply global safety regulations, expert in data analysis and evaluation of safety data
• 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
• Excellent verbal / written communication skills
• Excellent time management skills

It would be great if you also had the following:

• Certification from a professional medical writer\xe2\x80\x99s 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
• 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
• Ensuring to meet the requirements as in-Service Level Agreements and achieving all defined and agreed Key Performance Indicators in terms of quality, compliance and trainings
• Maintaining awareness of any performance issues within the team and taking steps for resolution
• Ensuring communication of important decisions/policies discussed with senior management or the client to the team

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)
At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.