4 Safety Writing Jobs

As a Senior/Lead Medical Reviewer with 1 3+ years of experience in Aggregate Reporting, Signal Management, or RMP, you will play a crucial role in our team. Your responsibilities will include overseeing the implementation of operational tasks in safety writing, monitoring service performance, and mentoring employees to ensure independent work within timelines, budget, and quality standards. Your duties will involve reviewing RMP/PSUR or any aggregate documents for medical cohesiveness, managing the logistical aspects of safety reports" development, and collaborating with authors from different line functions to meet client and Health Authorities" requirements. You will also be responsible for developing and distributing project-specific slides, participating in audits and inspections, maintaining trackers, and ensuring team members complete necessary training. Additionally, you will be involved in authoring and reviewing various reports such as RMPs, DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports. Your expertise will be crucial in finalizing these reports and resolving any arising issues, as well as supporting the drafting and implementation of SOPs or WIs. You will act as a point of contact for the aggregate team and clients, assist other teams as needed, and ensure team compliance in report delivery. Desirable Skills and Experience: - Proficiency in medical and Pharmacovigilance terminologies - Knowledge of GCP, GVP, ICH, USFDA guidelines, and other relevant regulations - Basic understanding of medical and therapeutic terminology - Familiarity with patient safety regulatory obligations - Good command of written and spoken English, additional languages are advantageous - Proficiency in MS Office applications (Word, Excel, PowerPoint) - Strong soft skills, including motivation, communication competence, organizational skills, reliability, commitment, and teamwork capacity Location: Bangalore, India Education: Graduate or Post-Graduate in Life Sciences, Pharmacy, Medicine, Dentistry, Allied Health Sciences, or related fields Position: Associate Department: Pharmacovigilance and Safety Employment Type: Full Time,

The responsibility of this role is to provide all clients, both internal and external, with high-quality service in a safe and cost-effective manner. You are expected to adhere to legal requirements such as the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3 as outlined in the Company's Health and Safety Manual. Your key responsibilities include: - Conducting quality reviews of assigned cases. - Compiling quality metrics based on reviews and identifying trends. - Assisting in client quality reviews and preparing corrective and preventive actions. - Ensuring implementation of CAPA results in coordination with project managers. - Reviewing various cases and safety reports for regulatory submissions and labeling documents. - Managing adverse events, product quality complaints, and medical information to meet timelines. - Participating in process reviews, designing training schedules, and contributing to process improvements. - Coordinating audits, developing Quality Management Plans, and supporting regulatory inspections. - Analyzing data, suggesting process improvement strategies, and responding to queries. - Executing drug safety data management processes and guiding safety associates. - Supporting sponsor during regulatory inspections or audits and responding to safety reports. Qualifications required for this role: - Bachelor's/Master's/PhD degree in relevant fields or equivalent experience. - Minimum of two years of experience in pharmacovigilance/safety writing. - Proficiency in medical and drug terminology, GCP, GVP requirements, ICH Guidelines, and regulatory requirements. - Technical proficiency with Microsoft Office applications. Preferred qualifications: - Experience in generating quality metrics, trend analysis, and coordinating corrective actions. - Knowledge of Medical Device reporting is desirable. Physical Demands/Work Environment: - Office environment with occasional travel required. This role offers an opportunity to contribute to quality operations, process improvements, and regulatory compliance in the pharmaceutical industry.,

Job Description: As the Director of Safety Writing at GSK, you will be leading the safety writing team to ensure the accurate, clear, and compliant preparation of Aggregate Reports and Risk Management Plans. Your role will involve a deep understanding of regulatory guidelines, effective leadership skills, and the ability to build a best-in-class capability to achieve organizational business goals related to safety writing. You will oversee the efficient preparation of high-quality safety writing deliverables that are strategically aligned and lead a global team of medical writers. Additionally, you will be responsible for optimizing internal and external resourcing, ensuring compliance, implementing best practices, fostering innovation, streamlining processes, and upholding standards of medical writing. Collaboration with the Head of Medical Writing to develop and drive departmental strategies will also be a key aspect of your role. Your leadership will be instrumental in aligning safety writing capabilities with business and operational needs, working closely with cross-functional safety teams for project clarity, and delivering high-quality safety documents that meet regulatory standards. Key Responsibilities: - Take accountability for all safety writing deliverables produced by the Medical Writing function. - Lead change initiatives to operate at the forefront of operational excellence. - Manage and lead line reports, including aspects of personnel management such as hiring, training, professional development, performance evaluations, compensation recommendations, promotions, teambuilding, and supervision of adherence to departmental procedures and health authority regulations. - Define and execute recruitment strategies to attract top talent. - Incorporate organizational considerations into strategic and operational decisions. - Create a compelling future vision and ensure it is measurable and aligned with organizational goals. - Demonstrate a track record of quality decision making and innovative problem resolution with significant operational impact. - Lead initiatives for process improvement, training, quality enhancement, and compliance. - Act as an industry thought leader, providing consultancy in areas like process improvement, pharmaceutical standardization, and implementation of regulatory guidelines. - Cultivate beneficial partnerships with external organizations to meet company objectives. - Oversee the identification and engagement of third-party partners, ensuring their performance and compliance meet business requirements. Basic Qualifications and Experience: - Minimum requirement of a master's degree in Life Sciences/Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.). A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine with patient exposure in a hospital-based setting is advantageous. - A total of 18+ years of experience, with at least 10 years in safety writing within the pharmaceutical industry or a large Contract Research Organization, demonstrating leadership skills. Ideal candidates will have expertise in applying FDA, EU, and ICH guidelines for pharmacovigilance in clinical trials and post-marketing, serving as an internal and external safety writing expert. - Experience working in matrix/multicultural environments and diverse settings, especially within hybrid teams. - Strong negotiation skills for proposing creative solutions to new challenges. - Strategic acumen with robust planning and organizational capabilities. - Proficiency in both written and spoken English. - Ability to mentor and discern essential information, ensure logical flow, clarity, accuracy, and appropriateness for target audiences, such as regulatory authorities. Inclusion at GSK: At GSK, we are committed to inclusion and encourage candidates to reach out if they require any adjustments during the recruitment process. Contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs. Why GSK: GSK is a global biopharma company focused on uniting science, technology, and talent to combat disease collectively. Our mission is to positively impact the health of billions of people and deliver sustainable shareholder returns. We value our people as the cornerstone of our success, striving to create an environment where individuals can thrive, grow, and contribute to our shared ambition of getting ahead of disease together. Important Notice to Employment Businesses/Agencies: GSK does not accept referrals from employment businesses/agencies concerning vacancies posted on this site without prior written authorization. It is essential for employment businesses/agencies to contact GSK's commercial and general procurement/human resources department for authorization before referring any candidates. Unauthorized actions by employment businesses/agencies will not be recognized as having consent or contractual agreement with GSK, and GSK will not be liable for any fees arising from such actions. If you receive unsolicited emails or job advertisements from email addresses not ending in gsk.com, please disregard them and notify us at askus@gsk.com for verification of the job's legitimacy.,

The ideal candidate for this position should have a qualification of B. Pharm / M. Pharm/ BAMS/ BHMS. The job is located in Mumbai and Pune, India. You should have a minimum of 3-4 years of experience in case processing/ safety writing and knowledge of SDEA management. It is essential to have experience in exchanging safety data / conducting reconciliations with business partners. Strong written and verbal communication / presentation skills are also required. Keeping updated with the latest technical / scientific developments related to PV is crucial for this role. As part of your responsibilities, you will need to initiate communications with internal stakeholders such as business teams and subsidiaries to understand the requirements of SDEAs. Following up with third parties/business partners to ensure SDEAs are in place is also a key responsibility. Timely exchange of safety data with partners and conducting adverse event reconciliation with partners are tasks that you will be expected to perform. If you meet the qualifications and are interested in this position, please share your CV on hr@fidelityhs.com.,