Sanofi is currently hiring for the Pharmacovigilance QC Team Lead position. This role involves leading the quality control activities within the pharmacovigilance department, ensuring compliance with regulatory standards, and overseeing the accuracy and completeness of pharmacovigilance data. The candidate will be responsible for managing a team, reviewing adverse event reports, and implementing QC strategies.
Job title: Pharmacovigilance QC Team Lead
- Location: Hyderabad
At Sanofi Consumer Healthcare, our Science Hub mission is to empower our consumers to take Health in their Hands! With your talent and ambition, we can do even more to build our Sciences activities and develop breakthrough innovations for consumers worldwide. Your job, as Global Regulatory Maintenance Team Lead within our Scientific Communications/Education
Main responsibilities:
- Responsible for collaborating with PV Operations Head and Medical Safety Head within Global PV team to provide QC team support for activities for assigned consumer safety topics in company’s portfolio.
- Responsible for managing the team supporting QA/QC activities for multiple tasks in Pharmacovigilance in alignment with Global Consumer Safety Team. This will also include collaboration with goals & objectives of the Global Medical Safety and PV Operations teams.
- Directly oversee and lead PV Quality Check (PV QC) team located at India (Hyderabad) hub location to QC case management (Case Processing), literature surveillance, periodic reports and signal & risk management activities.
- Collaborate with global Medical Safety Head and PV Operations Head for coordination of QC of above-mentioned activities.
- Work closely with resources working on these activities at vendor location to ensure proper alignment of Ways of Working.
- Assign tasks and projects to team members, ensuring efficient workflow and adherence to deadlines. Develop KPIs for different tasks and align with PV Quality group on management of those KPIs. Plans, schedules, and manages the daily work activities within the team to meet or exceed established key performance indicators (KPIs).
- Provide leadership and mentorship to the PV QC team at India (hub) location and support the development of team members professionally.
- Promote a culture of continuous learning and professional development within the PV team.
- Provide regular training and development opportunities to enhance team performance.
- Develops and implements, in alignment with Global Consumer Safety team, procedures, systems and training activities to develop an appropriate level of expertise within the above-mentioned PV topics.
- Conduct regular performance reviews, provide feedback, and support professional development of team members aligned with appropriate functions from Global Consumer Safety team.
- Oversee multiple QC activities within PV QC group at local hub location.
- Analyze quality control data to identify trends, risks, and areas for improvement.
- Ensure compliance with global PV regulations, including FDA, EMA, and ICH guidelines.
- Work closely with GSOGL (Global Safety Operations Group Lead) & GPTL (Global Pharmacovigilance Team Lead) at India (hub) location.
- Support PV Operations team and participate in regulatory inspections and audits.
- Address audit findings and implement corrective and preventive actions (CAPAs) related to QC work.
- Stay current with advancements in pharmacovigilance and drug safety and integrate new technologies and methodologies.
- Collaborate with Global Science CoE Head to support on any additional activities.
About you
- Experience: 8-10 years of experience in Quality Control & Analysis within pharmacovigilance activities.
- Experience in consumer healthcare, pharmaceuticals, or related industries is preferred.
- At least 4 years of experience in a leadership or managerial role within pharmacovigilance.
- Strong knowledge of global PV regulations and guidelines (e.g., FDA, EMA, ICH).
- Proven track record of leading and mentoring a team of PV-QC professionals.
- Experience in performance management, conducting performance reviews, and supporting professional development of team member.
- Soft skills: Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment.
- Technical skills: Strong knowledge of GxP and global PV regulations, PV systems and PV processes
- Education: Scientific degree (e.g., BS, MS, Pharmacy) or other degree with the equivalent combination of relevant education and professional experience.
- Languages: Excellent knowledge of the English language (to read, write, and speak)