ProPharma Hiring Pharmacovigilance Safety Scientist

ProPharma Hiring Pharmacovigilance Safety Scientist – 2+ Years Experience | Bangalore | Full-Time ProPharma is inviting applications for the position of Pharmacovigilance (PV) Safety Scientist at its Bangalore location in India. This is a full-time opportunity under the Pharmacovigilance and Benefit-Risk division, offering an onsite or hybrid work model. Professionals with 2+ years of experience in pharmacovigilance, aggregate report writing, signal detection, and regulatory safety documentation are encouraged to apply. This role is critical in supporting global drug safety operations, including PSUR, PBRER, PADER, DSUR, and Risk Management Plan (RMP) authoring for regulatory submissions to international health authorities such as US FDA and EMA. If you have strong expertise in safety data analysis, medical writing, and compliance with ICH guidelines, this opportunity offers strong exposure to global pharmacovigilance systems and regulatory frameworks. Company Overview For over two decades, ProPharma has partnered with pharmaceutical, biotechnology, and medical device organizations worldwide to support safe and compliant product development. The company operates across the full product lifecycle through its advise-build-operate model, delivering services in regulatory sciences, pharmacovigilance, clinical research, medical information, quality compliance, and R&D technology. ProPharma’s pharmacovigilance teams play a key role in ensuring benefit-risk evaluation, post-marketing surveillance, signal management, and regulatory reporting. By maintaining strict adherence to global safety standards and evolving regulatory requirements, the organization helps life sciences companies maintain compliance while safeguarding patient health. The PV Safety Scientist role directly contributes to global drug safety surveillance, regulatory risk mitigation, and quality-driven pharmacovigilance operations. Job Role & Responsibilities As a Pharmacovigilance Safety Scientist, you will support the Benefit-Risk group by managing day-to-day pharmacovigilance activities and ensuring timely submission of safety documents to health authorities. Aggregate Report Authoring • Author aggregate safety reports including PSURs/PBRERs, PADERs, Annual Reports, DSUR, and other regulatory safety submissions. • Prepare and update Risk Management Plans (RMPs) in compliance with international regulatory requirements. • Develop Signal Management Reports based on safety data trends and analysis. Data Review & Analysis • Perform literature searches and validity checks to support safety reporting. • Extract and validate safety data including Reference Safety Information (RSI), sales data, previous reports, and signal outputs. • Generate Line Listings (LL) from safety databases for regulatory reporting. • Analyze and interpret large volumes of pharmacovigilance data within defined regulatory timelines. Compliance & Quality Oversight • Ensure all deliverables comply with ICH-GCP, FDA, EMA, and other global pharmacovigilance regulations. • Support reconciliation of safety trackers and internal quality metrics. • Identify deviations and contribute to CAPA development where required. • Author or update SOPs and work instructions in line with pharmacovigilance best practices. Collaboration & Client Interaction • Liaise with senior PV scientists, management, and cross-functional teams. • Provide support for high-priority and ad-hoc pharmacovigilance projects. • Participate in internal and client discussions regarding quality and regulatory compliance. • Maintain strong documentation standards and ensure on-time regulatory submissions. This role requires scientific precision, strong analytical skills, and a deep understanding of global pharmacovigilance regulations to ensure patient safety and regulatory compliance. Eligibility / Qualifications Educational Qualification Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences, or related healthcare field. Relevant Courses: B.Pharm, M.Pharm, PharmD, BSc Nursing, MSc Nursing, BSc Life Sciences, MSc Life Sciences, MSc Biotechnology, MSc Microbiology, MSc Pharmacology, Clinical Research. Experience • Minimum 2+ years of experience in pharmacovigilance. • Experience in aggregate report writing, literature screening, and signal detection. • Exposure to regulatory safety documentation and benefit-risk evaluation. • Experience participating in quality discussions and safety metrics compilation. Key Skills • Strong knowledge of ICH-GCP, FDA, EMA, and global PV regulations. • Excellent medical writing and scientific data interpretation skills. • Strong analytical and problem-solving abilities. • Proficiency in MS Office tools and web-based safety databases. • Ability to work effectively in cross-functional and matrix environments. • High attention to detail and quality-focused approach. Location & Employment Details • Location: Bangalore, India • Work Model: Onsite / Hybrid • Employment Type: Full-time • Job Requisition ID: JR 7763 Salary details are not publicly disclosed. Compensation is aligned with industry standards for pharmacovigilance scientists in global regulatory consulting organizations. Application Process Interested candidates can apply directly through the official ProPharma career portal: Apply Here: https://propharmagroup.wd1.myworkdayjobs.com/ppgcareers/job/India/Pharmacovigilance-Safety-Scientist_JR7763-1?source=LinkedIn All applications are personally reviewed by ProPharma’s recruitment team. Candidates will receive an update regarding their application status after review. Frequently Asked Questions (FAQs) 1. What reports will the PV Safety Scientist author? The role includes authoring PSURs, PBRERs, PADERs, DSURs, Risk Management Plans, and signal management reports. 2. Is prior experience in aggregate report writing mandatory? Yes, hands-on experience in aggregate safety reporting and literature review is required. 3. What regulatory knowledge is essential for this role? Candidates must understand ICH-GCP, FDA, EMA, and global pharmacovigilance regulations. 4. Is this role suitable for freshers? No. A minimum of 2 years of pharmacovigilance experience is required. 5. Does ProPharma allow hybrid work? Yes, the company supports onsite and hybrid working models based on location and team requirements. Summary Company ProPharma Vacancies Pharmacovigilance Safety Scientist Required Education B.Pharm, M.Pharm, PharmD, BSc Nursing, MSc Nursing, BSc Life Sciences, MSc Life Sciences, MSc Biotechnology, MSc Microbiology, MSc Pharmacology Experience Minimum 2+ Years in Pharmacovigilance & Aggregate Report Writing