Recruitment for M.Pharm, M.Sc as Medical Manager at Pfizer
Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post : Medical Manager - GMAIST
• Researching literature databases, internal and external repositories to support the evaluation of Health Hazard Assessments and the benefit-risk of Pfizer products.
• Support for major regulatory agency submissions, clinical overviews, health hazard assessments, listings and summarizing the results of the above research to the required standard.
• Reviewing therapy area sales training material for accuracy and alignment. This may also include supporting the registry work.
• Performs pre-medical review of promotional material to ensure it is accurate, truthful, not misleading and aligned with Core Claims, Common Technical and/or other regulatory documents.
• Supervision and review of the Global Medical Product Evaluation (GMPE), promotional material and publications work performed by the associates, in order to provide high quality and timely service.
• Supporting all combination medical devices in PBG with regards to providing medical input into Hazard Analysis (HA), specifically:
• Analyze Pfizer Global Supply (PGS) product complaint data, Adverse Events (AE) cases from safety database and clinical literature to provide data to Pfizer for assigning probability scores, severity, and a harms list.
• Conduct Clinical Literature search.
• Review of Harms list provided by Global Medical and Safety Lead and provide additional harms from above data sources (complaints, AEs, clinical literature).
• Recommend “severity of harm” score based on review of data and assign appropriate risk category.
• Provide potential MedDRA preferred terms.
• Provide link to complaint subclass for harms.
• Provide medical/scientific rationale for harms, probability severity scores of each hazardous situation based on clinical literature review, complaint review, and AE review.
• Develop reference binder containing all references utilized for the development of Medical Reference Document (MRD).
• Create and/or update existing Clinical Evaluation Report (CER):
• Conducts a search of the literature and screen publications and safety database cases to include in report.
• Analyzes source data (existing risk documentation, Information For Use (IFU), design dossier, submission, technical data, requirements, and/or other data sources) and utilize as input into the CER.
• Creates a Clinical Evaluation Plan for review by Pfizer Global Medical Lead.
• Analyzes specific clinical data (such as post-market surveillance, pre-clinical studies) according to the recommendations of MEDDEV 2.7.1 Rev 4.
• Develops a section for the device in the write-up of the State of the Art section along with the approved equivalent and benchmarking devices.
• Provide completed CER to Global Medical Lead for final review and approval.
• Ensuring delivery of all required activities within expected timelines and on budget.
• Develop abstracts, posters, manuscripts, congress presentations and slide decks for the HBU as per the required needs.
• Providing support to the Medical Affairs group including but not limited to literature reviews and summaries, preparation of slide decks
• Creating documents pertaining to clinical data, company data, published literature and other data to support the maintenance and defense of our products. Some examples of such document include briefing documents to support meetings with regulatory agencies, clinical overviews and clinical efficacy section in support of Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Periodic Safety Update Reports (PSURs), Addendum Reports, Health Hazard Assessments Clinical Evaluation Reports, Hazard Analysis, critical review and analysis of the medical literature and responses to clinical and safety questions from regulatory authorities.
• Providing expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents.
• Assessing document requirements, gauging document complexity, and identifying information gaps or other potential issues. In collaboration with the relevant GMPE TA Lead, the author proposes or contributes to strategies to resolve any identified issues.
• Clinical and scientific medical writing, editing, and quality control (QC) review for regulatory documents including clinical study reports, safety narratives, protocols, protocol amendments, investigator brochures and submission documents.
• Pharmacovigilance and drug safety writing including: Periodic Adverse Drug Experience Reports (PADERs), CERs, PSURs, and Development Safety Update Reports (DSURs).
• Manuscript writing including researching, organizing, compiling, interpreting and quality checking various types of technical and/or medical information.
• Medical communication writing including research and authoring of global medical standard response letters (“Dear Doctor” letters).
• Creating slides, abstracts, training materials, and style guides, as needed for our clients and their diverse audiences.
• Adapting writing to different types of clients and audiences from the health care professionals and technical people to the consumer audience.
• Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams in a timely manner of any definite or potential deviations.
• Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
• Deliver assigned documents on or before deadline, alerting project teams in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
• Understand relationships and dependencies between documents and analyses produced for regulators, e.g., Risk Management Plans (RMPs), CERs, Hazard Analysis, Benefit-Risk Assessments, DSURs, PBRERs and ACOs.
• Collaborate with other lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents.
• 3 to 4 years relevant experience for medical graduates, PhDs & masters in life sciences/ more than 6 years relevant experience for science graduates. Minimum 3 years of experience in medical writing within an agency, CRO, Pharma / Biotech Company.
• Prior experience in using search tools, developing search strings and assessing search results is preferred.
• Graduate/Post Graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees.
• Writing skills: Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively.
• Analytic skills: Utilize tools such as OvidSP and other bibliographic databases such as PubMed, Medline, Embase, and Biosis. Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.
• Language skills: High fluency in written English and strong functional fluency in spoken English.
• Personal skills: Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
• Interpersonal skills: Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy. Ability to work well with all levels and roles in cross-functional, global teams. Ability to mentor more junior colleagues and external vendors.
• Regulatory knowledge: Familiarity with global regulatory guidance especially International Conference on Harmonisation (ICH), Food and Drug Administration (FDA) and European Medicines Agency (EMA) relevant to clinical and safety.
• Software: Previous experience with software commonly used to present and analyze data and experience with searching academic databases. (Word, PowerPoint, Excel) is preferred.
• Epidemiology: Familiarity with epidemiologic principles and concepts is desirable.
• Reports directly to the Senior Medical Manager.
• Works closely with GMPE TA Leads and Global Medical Affairs Leads.
• Interacts with Regulatory, Safety, PGS and Medical Affairs colleagues at local, regional and global level.
Qualification : B.Sc, B.Pharm, M.Pharm, M.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : GMAIST
End Date : 20th September, 2019
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