How you’ll spend your day
Participate in activities of literature review. Design and implement comprehensive literature search strategies on specific products. Knowledge of database: Embase, Medline, Pubmed, Ovid, etc.
Assess the impact of regulatory changes on the current process.
Contribute to simplification of processes.
Knowledge and expertise in Teva portfolio.
Support pharmacovigilance teams like case processing, training teams, quality assurance, audits and inspections etc.
Act as a consultant or SPOC for various case related activities and maintain knowledge repository of the process updates/ regulatory changes on real time.
Effective communications to be maintained with internal (related departments and units) & external (partners, authorities, vendors) stake holders in order to run the process as transparent as possible.
Ensure that quality data is analyzed for any trending and to prepare team for process stabilization.
Ensure regulatory compliance by following internal reporting key performance indicators for the unit are met.
Independent operations and self-promoted initiatives are expected to interpret and make valuable decisions in ever changing and dynamic requirements from regulators.
Being part of transitions to the team and to other teams and certification of the teams on the same.
Conduct various interactive activities like workshops, trainings, sessions to educate the team on the existing and on predicted error trends for process improvements.
Provide the analytical support for the peers and managers in investigations and analysis of various trends as a part of audits, and inspections.
Mentoring the new hires with case processing knowledge transfer, evaluating their progress close to perfection during their initial phases of learning curves.
Perform other tasks assigned by the direct manager.
Your experience and qualifications
Any life sciences/pharmaceutical/healthcare professional graduate (B. Pharmacy, M. Pharmacy, Pharm D, BDS).
Minimum of 3-4 years of experience in pharmacovigilance including literature review process in ICSR
Experience in patient safety/pharmacovigilance: solid knowledge in pharmacovigilance concepts, regulations, and procedures.
Advanced knowledge of Microsoft Office platforms.
Flexible to adapt to shifting team priorities.
Excellent communication skills including written, verbal, and non-verbal.
Excellent Interpersonal and people skills. Good analytical skills and problem-solving skills.
