Associate Manger - Pharmacovigilance

About Shalina Healthcare: Shalina Healthcare is one of the largest pharmaceutical companies in sub-Saharan Africa. For the last 40 years we have made it our mission to provide quality medicines to those who need it the most. We manufacture and distribute branded prescription and over-the-counter pharmaceutical and consumer products, across a broad range of therapeutic groups, including anti-malarial, antibiotics, anti-inflammatory and nutrition. We have a track record few can match and our brands are among the most trusted in Africa. We are proud of our history and have big ambitions for the future. Our vision for 2030 is to be the health champion of Sub-Saharan Africa. To achieve this, we are looking for the right people to join us and create a lasting impact not just within our company but on the communities we serve. Everyone in our company has a crucial role to play, and we are looking for people who identify with our Core Values and are as passionate about our Mission as we are. The Global Supply Organization is a multi-continental Function that comprises of the entire Value Chain from product conceptualization to delivery to the commercial front. Within the Global Supply Organization are included; Research & Development, Project Management, Manufacturing, Quality, Supply Chain Management and Logistics. Role: Pharmacovigilance Specialist Designation: Associate Manager Base location: Pawane, Navi Mumbai, India Reporting To: Head Medical Affairs What you become a part of: Responsible for monitoring, assessing, and reporting the safety profile of the company's products throughout their lifecycle. Ensures compliance with global pharmacovigilance (PV) regulations and supports the safe use of medicinal products in collaboration with Medical Affairs. Accountable for the strategic direction, oversight, and operational integrity of the company's global pharmacovigilance system. Ensures patient safety, regulatory compliance, and the effective functioning of the PV system across the product lifecycle, while serving as a key safety partner to Medical Affairs and executive leadership. What to expect: Collect, process, and report adverse events (AEs), serious adverse events (SAEs), and product complaints within regulatory timelines.Perform case processing activities: triage, data entry, medical assessment, coding (MedDRA), and quality review of Individual Case Safety Reports (ICSRs).Contribute to aggregate safety reports (PSUR/PBRER, DSUR, PADER) and signal detection/management activities.Support risk management planning, including Risk Management Plans (RMPs) and Risk Minimization Measures.Ensure compliance with GVP, ICH guidelines, FDA, EMA, and local health authority requirements.Liaise with Medical Affairs, Regulatory, Clinical, and Quality teams on safety-related matters.Provide PV input into medical/scientific materials, advisory boards, and field medical activities.Support safety data reconciliation with partners, vendors, and licensing agreements.Respond to safety queries from health authorities and internal stakeholders.Maintain inspection/audit readiness and support CAPA implementationWork with the Medical Affairs head for medico marketing activitiesLiase and work with the NPD teams for SMPC preparation, product queries, New product evaluations, etc.Leadership & Strategy Define and lead the global PV strategy, aligning safety objectives with medical, regulatory, and business goals.Build, mentor, and manage the pharmacovigilance function, fostering a culture of safety and continuous improvement.Serve as a senior safety advisor to executive leadership and cross-functional governance bodies.System Oversight & Compliance Own and maintain the Pharmacovigilance System Master File (PSMF) and the overall PV system.Ensure full compliance with global regulations (GVP, ICH, FDA, EMA, and local authorities).Act as, or oversee, the EU Qualified Person for Pharmacovigilance (QPPV) and equivalent local safety officers.Ensure inspection and audit readiness; lead responses to health authority inspections and manage resulting CAPAs.Safety Surveillance & Risk Management Oversee signal detection, benefit-risk assessment, and risk management activities (RMPs, risk minimization measures).Prepare and manage aggregate safety reports (PSUR/PBRER, DSUR, PADER) and key safety documents.ICSR management Lead safety decision-making, including escalation of emerging safety issues to safety committees.Preparing and handling PV Audits.Cross-Functional & External Engagement Partner with Medical Affairs, Regulatory, Clinical, Quality, and Commercial functions on safety strategy.Partner with the OU PV/ Regulatory personnel to monitor AEs, SAEs, etcRepresent the company with regulators, partners, and safety data exchange agreements.Oversee PV vendor and licensing partner oversight, including safety data exchange agreements (SDEAs). Qualifications Education: BAMS/ MBBS/ B Pharma/ M Pharma/ Pharm .