Website:
waymade.co.uk
Job details:
1. Pharmacovigilance Operations
- Oversee and manage outsourced day-to-day PV activities, including case intake, processing, medical review, and submission of Individual Case Safety Reports (ICSRs).
- Ensure timely reporting of adverse events to regulatory authorities (e.g., MHRA, EMA or other agency) and partners.
- Oversee literature screening and management of safety data from various sources.
- Review PSMF and PVMP as per global requirements.
- Conduct due diligence for new submission molecules with regards to current PV capability.
2. Regulatory Compliance
- Ensure compliance with global pharmacovigilance regulations (EU & UK GVP modules, ICH guidelines).
- Maintain inspection readiness and support regulatory inspections and audits. Co-ordinate for PV audit plans with relevant internal and external stakeholders.
- Ensure adherence to internal SOPs and contribute to development and updates of PV procedures.
- Preparation of Summary of product characteristics and product information.
- Maintain and compile product information in alignment with the reference product database to support regulatory submissions.Preparation of non-clinical and clinical overview, summaries for dossier submission and toxicity related information.
- Handling product quality complaints or enquires related to PV activities.
- Manage reconciliation from all PV service providers.
3. Signal Detection & Risk Management
- Lead or support signal detection activities, including data review and evaluation.
- Contribute to benefit-risk assessments and signal validation processes.
- Support preparation and maintenance of Risk Management Plans (RMPs) and Risk Minimisation Measures.
4. Aggregate Reporting
- Oversee preparation, review, and submission of aggregate safety reports such as:
- Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Ensure compliance with submission timelines and regulatory expectations.
5. Vendor & Stakeholder Management
- Manage relationships with PV service providers (EUQPPV and local PV service provides) and ensure oversight of outsourced activities.
- Act as a key point of contact for internal stakeholders (Regulatory, QA teams).
- Provide inputs and support safety data exchange agreements (SDEAs) with partners.
6. Quality & Process Improvement
- Monitor PV metrics and KPIs to ensure high-quality performance.
- Identify process improvements and implement best practices.
- Support CC, CAPA management related to PV activities.
Qualifications & Experience
Education
- Degree in Pharmacy, Medicine, or related field
- Advanced degree (e.g., MSc, PharmD, PhD) is desirable
Experience
- Typically 8+ years of experience in pharmacovigilance or drug safety
- Experience in case processing, aggregate reporting, and signal detection, PSMF review, handling product complains.
- Prior experience in managing PV activities or teams preferred
Job Location: Vadodara,Gujarat
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