ResponsibilitiesPeople: (1) Maintain effective relationship with the end stakeholders (medical scientific community) within the allocated Global Business Unit and product – with an end objective to develop education and communication content as per requirement; (2) Interact effectively with health care professionals on publication content; and (3) Constantly assist junior writers in developing knowledge and sharing expertise Performance: (1) Provide publication/medical education material (slide deck, abstract, poster, manuscript etc.) as per agreed timelines and quality and (2) Provide strategic support with individuals and institutions, which may serve as resources for publications purpose Process: (1) Develop complex publication/medical education material; (2) Support medical communication and develop subject matter expertise for the assigned therapeutic area(s); (3) Assist the assigned scientific communication team in conducting comprehensive publication-need analysis; (4) Implement the publication plan and associated activities for the year identified for the region; (5) Work with selected vendors within the region to deliver the required deliverables as per defined process; (6) Leverage advanced training delivery tools and techniques thereby enhancing the effectiveness of training delivery; and (7) Design an overall plan of action based on end-user feedback and improve course content and delivery Stakeholder: (1) Work closely with scientific communication teams in regions/areas to identify publication need and assist in developing assigned deliverables and (2) Liaise with medical department to prepare relevant and customized deliverables Qualification & ExperienceExperience: 4+ years of experience in content creation for the pharmaceutical/healthcare industry, or academia Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment Technical skills: As applicable (including but not limited to therapeutic area/domain knowledge exposure; publication submission; and/or project management) Education: Advanced degree in life sciences/pharmacy/similar discipline or medical degree Languages: Excellent knowledge of English language (spoken and written) 

Responsibilities Responds to unsolicited consumer, health care professional and other external customer requests for medical and safety information received via telephone, website/e-mail, letter, fax, and scientific meetings on behalf of ProPharma’ s pharmaceutical clients.  Provides labeled and unlabeled medical/safety information responses in accordance with regulatory requirements, industry standards and client and ProPharma internal policies and practices.  Accurately identifies, documents and reports adverse events, pregnancy reports, special situation events and product complaints in a clear and concise manner per government regulations, ProPharma Standard Operating Procedures (SOPs) and client Working Practices (WPs).  Ensures tasks are completed within the deadlines documented in the agreed ProPharma SOPs and WPs.  Formulates and provides accurate responses utilizing approved labeling and company standard responses, published literature and other data. Assists with writing custom medical information responses utilizing this data.  Logging all enquiries handled in an accurate, comprehensive, and timely fashion into Inquiry Handling Systems. Quality Assurance  Maintains quality in all areas of the job, including performing quality checks on Adverse Events, Product Quality Complaints, correspondence, and enquiries logged into the Inquiry Handling Systems General  Provides after-hours coverage on a rotated basis subject to business requirements.  Adheres to company and country-specific privacy policies, ensuring any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations described in ProPharma SOPs and the Confidentiality Statement within the Contract of Employment.  Complies with the Company’s health and safety policies.  Other activities as assigned as delegated by the ManagerQualification & Experience Life science degree OR Nursing degree (RN/BS/BA/MS) OR Pharmacy degree  Excellent verbal and written communication skills, including proofreading, professional telephone etiquette and empathetic customer service skills.  Ability to write in a fluent and grammatically correct manner in the target language for the role  English language proficiency. Japan-based roles only: TOEIC 800=  Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards.  Strong cognitive abilities, including verbal reasoning, critical thinking and analytical ability.

ResponsibilitiesAggregate Safety Reports & Documentation: Independently lead the preparation/update of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions, including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overviews (ACOs), Investigational New Drug Annual Report (INDARs), Semi-Annual Safety Reports (SASRs), Annual Risk- Benefit Evaluation (ARBE) report , Safety statements, Health Hazard Evaluation (HHE), Clinical Overview (CO) and any other ad hoc safety documents, ensuring scientific accuracy, regulatory compliance, and timely delivery. Serves as an SME for safety reports, developing templates, guiding teams, and creating strategies to address complex regulatory and data presentation challenges. Facilitate operational coordination, including scheduling and leading meetings, drafting agendas and minutes, tracking action items, and ensuring timely follow-up on open issues to support seamless project execution. Ensure compliance and quality across aggregate safety reports, performing detailed reviews for factual accuracy and internal consistency across documents such as but not limited to PBRERs, DSUR etc.). Manage the distribution of final reports to stakeholders, including partners, affiliates, and health authorities, in accordance with agreed timelines, distribution lists, and email templates (as required). Safety Analysis & Signal Management: Leads advanced safety signal detection and management for key products, integrating diverse data sources and innovative analytical approaches to identify emerging safety concerns. Provides expert interpretation of complex safety data patterns and trends across product lifecycles. Leads clinical safety activities for complex molecules, contributing to strategic decisions as part of the global safety team. Collaborates with cross-functional teams to analyze complex safety data and provide support as part of the study management team. Directs literature review strategies and critically evaluates scientific evidence for inclusion in safety documents. Leads safety evaluations for complex molecules and sensitive indications, providing scientific direction that supports clinical strategy and strengthens regulatory positioning through high-quality safety reports and responses. Qualification & Experience    Preferred qualifications include a university degree in Life Sciences, Health, or Biomedical Sciences—such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy etc. Or equivalent combination of training and work experience. Clinical exposure in hospital-based environments is considered advantageous.Strong analytical and problem-solving abilities, with the capability to independently evaluate complex data and draw meaningful conclusions. Exceptional communication skills, both verbal and written, including the ability to produce clear, concise, and accurate medical/scientific content. Excellent interpersonal and collaboration skills, fostering productive relationships with clients, cross-functional teams, and stakeholders. Effective organizational and prioritization skills, with the ability to manage multiple tasks enthusiastically and maintain attention to detail under tight timelines. Client-focused mindset, demonstrating flexibility, professionalism, and a proactive approach to meeting client expectations and expanding business opportunities. Strong negotiation and stakeholder management skills, ensuring alignment of resources, timelines, and deliverables across teams and departments. Cultural awareness and adaptability, enabling effective communication and collaboration in global, multicultural environments. Proficient in computer operations and IT tools, with expertise in web-based applications and familiarity with the Windows operating system and Microsoft Office suite (Word, Excel, PowerPoint). Knowledge and Experience: Prior experience in pharmacovigilance, or related fields is preferred. Demonstrates Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts.:

ResponsibilitiesAggregate Safety Reports & Documentation: Leads the preparation of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions, including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overviews (ACOs), Investigational New Drug Annual Report (INDARs), Semi-Annual Safety Reports (SASRs), Annual Risk- Benefit Evaluation (ARBE) report , Safety statements, Health Hazard Evaluation (HHE), Clinical Overview (CO) Develops strategic approaches for challenging safety submissions, incorporating innovative data presentation techniques to enhance clarity and regulatory impact. Reviews and approves high-complexity safety documents, ensuring scientific accuracy, regulatory compliance, and alignment with product strategy. Coordinates multi-document submissions, ensuring consistency and integration across safety documentation packages. Provides expert guidance on evolving global regulatory requirements and advises on their implications for safety documentation. Manages meeting logistics including scheduling, agenda drafting, minute preparation, and tracking of action items, ensuring timely follow-up and resolution of open issues. Safety Analysis & Signal Management:Designs and implements advanced signal detection plans tailored to specific product profiles and diverse data sources. Leads signal detection for priority products by conducting expert-level analyses to uncover subtle safety signals and complex data patterns. Develops robust literature review strategies and critically evaluates complex scientific evidence or inclusion in PSRs, drug safety reports, and RMPs. Supports clinical safety and ad-hoc safety activities for complex molecules, contributing to strategic safety evaluations. Authors and reviews high-priority signal assessment reports and health authority response documents, resolves data challenges, and enhances decision-making through expert analysis and innovative visualizations. Risk Management Plan:Leads the preparation, updating, and integration of Risk Management Plans (RMPs) and Company Core-RMPs (CC-RMPs) across multiple regulatory regions and product types, ensuring alignment with evolving safety profiles and strategic objectives. Prepares and handles reviews of health authority response documents, incorporating safety data and regulatory insights to address queries and support submissions of RMPs. Oversees Reference member state (RMS) updates, ensuring consistency with client conventions, global regulatory expectations, and internal SOPs. Provides strategic input on risk minimization measures and benefit-risk communication, tailoring content to diverse regulatory audiences. Collaborates with cross-functional teams to ensure RMPs are scientifically robust, compliant, and aligned with the overall safety strategy. Qualification & Experience    Preferred qualifications include a university degree in Life Sciences, Health, or Biomedical Sciences—such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy etc or equivalent combination of training and work experience. Clinical exposure in hospital-based environments is considered advantageous. Demonstrates advanced analytical thinking and problem-solving skills to interpret complex safety data and derive meaningful conclusions to support benefit-risk assessments. Possesses strong scientific writing and communication capabilities, ensuring the production of clear, accurate, and regulatory-compliant documents. Strong capability to lead and collaborate across cross-functional, global teams and build trusted client relationships. Excels in organizational and time management, with the ability to prioritize tasks, manage multiple high-impact projects, and consistently meet deadlines. Proficient in medical writing tools and MS Office applications, with working knowledge of pharmacovigilance databases and coding dictionaries such as MedDRA and WHO-DD. Proactive in adopting new technologies, driving process improvements, and applying innovative approaches to safety documentation. Knowledge and Experience: Prior experience in pharmacovigilance, or related fields is preferred. Demonstrates Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts.

ResponsibilitiesPrioritizes, and performs the day-to-day operations of Clinical Transparency or Public Disclosure, ensuring the timely completion, review and approval of registration, updates and results disclosure activities or public disclosure strategy plans and public disclosure tracking mechanisms for studies and assets conducted globally. Makes appropriate decisions regarding the applicability and timing of clinical transparency or public disclosure activities according to national laws, regulations, industry guidance and corporate position. Manages the review and approval process for Clinical Transparency (clinical trial registrations, updates and results disclosures) and related documents (plain language and redacted documents) or public disclosure strategy plans and public disclosure tracking mechanisms, including communication with partner companies or collaborators. Facilitates periodic review of active registrations or public disclosure strategy plans to ensure records are updated or verified as required. Uses appropriate problem solving to determine escalation of issues to management. Addresses inquiries related to clinical transparency and related documents or public disclosure activities. Interacts and collaborates across various departments and management levels within Astellas to ensure open and effective communication. Provides feedback to clinical transparency or public disclosure leadership resulting from new and updated transparency requirements. Ensures compliance with evolving clinical transparency or public disclosure requirements, including retrospective review and work as necessary. Contributes toward the continuous improvement of global clinical transparency or public disclosure processes, procedures, and standards. Establishes and maintains global working relationships.Qualification & ExpeirenceBachelor’s Degree, or equivalent experience required. Proficient organizational skills and high attention to detail. Self-directed and motivated, with ability to work without significant direct supervision, asking questions when necessary. Ability to manage multiple tasks and readily switch activities to accommodate priority needs. Proficient computer skills, including experience with MSWord and Excel. Healthcare professional background preferred. Preferred Qualifications 2 years pharmaceutical industry experience in writing content for Clinical Transparency purposes. Clinical trials experience including study management, statistics, medical writing and / or data management preferred. Working knowledge of clinical drug development and clinical trial protocols preferred.