Global Safety Operational Group Lead

Within the CHC – Consumer Safety organization, under the direction of the Global Science Centre of Excellence (CoE) Lead, the Global Safety Senior Manager (GSSM) will provide operational leadership to the chosen team managing activities related to safety reporting in clinical studies, literature management, periodic reports, PV agreements, case management and PV systems and data analytics in alignment with Global Consumer Safety group PV Operations team.

The GSSM is responsible for collaborating with PV Operations Head, Global case management lead and PV Systems Head within PV Operations to provide team support for activities for assigned consumer care products in company’s portfolio.

The role is also responsible for managing the team supporting daily activities such as generating searches and output in support of departmental data requests, leading reporting requests (DSURs/PBRERs), supporting systems and analytics personnel in alignment with PV operations team. This will also include collaboration with goals & objectives of PV Operations team.

• Directly oversee and lead Global Safety Operations team located at India (Hyderabad) hub location to operate case management, literature surveillance, periodic report, partner management and data analytics activities.
• Collaborate with global PV Operations Head for coordination of above-mentioned activities.
• Work closely with resources working on same topics at vendor location to ensure proper alignment of Ways of Working.
• Provide leadership and mentorship to the PV Operations team members at India (hub) location.
• Plans, schedules, and manages the daily work activities within the team to meet or exceed established key performance indicators (KPIs).
• Promote a culture of continuous learning and professional development within the PV team.
• Conduct regular performance reviews, provide feedback, and support professional development of team members aligned with global PV Operations team.
• Oversee multiple activities within PV group at local hub location.
• Ensure compliance with global PV regulations, including FDA, EMA, and ICH guidelines.
• Support PV Operations team and participate in regulatory inspections and audits.
• Address audit findings and implement corrective and preventive actions (CAPAs).
• Provide lead on PV Agreements. 
• 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: Minimum of 8-10 years of experience in pharmacovigilance operations.
• Experience in consumer healthcare, pharmaceuticals, or related industries is preferred.
• Strong Leadership skills with at least 4 years of experience in a leadership or managerial role within pharmacovigilance.
• Experience in performance management, conducting performance reviews, and supporting professional development of team members.

• Soft skills: Stakeholder management; project management, communication skills; strategic thinking and ability to work independently and within a team environment; Strong analytical and problem-solving skills; Ability to work collaboratively in a cross-functional team environment.
• Technical skills: Strong knowledge of global PV regulations, Signal and Risk Management, Benefit Risk, toxicology, and overall Medical Safety activities,  Regulatory and company requirements, specifically pharmaceutical drug Regulations, e.g. EMA/FDA/ICH Regulations, Basic Continuous improvement management Strong knowledge of global PV regulations and guidelines (e.g., FDA, EMA, ICH). Proven track record of leading and mentoring a team of PV professionals.

• 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 English language (spoken and written)