Job Description

Drug Safety Physician (Gurgaon: On-site) - DDReg pharma Job purpose To perform medical review and oversight of processing for all types of safety events, and other medically-related project information. Provide medical oversight and completion of analysis of similar events, company causality assessment, and expectedness assessment, review of MedDRA coding, causality assessment signal detection, risk management, and pharmacovigilance oversight for assigned projects. Duties and responsibilities Reviewing and analyzing adverse event reports, clinical trial data, and other safety information related to drugs. Identifying and assessing safety risks associated with drugs, and making recommendations for managing or mitigating those risks. Communicating safety information to regulatory agencies, healthcare professionals, and the general public. Collaborating with other members of the drug development team, including pharmacologists, toxicologists, and statisticians, to ensure that safety issues are adequately addressed. Participating in the development of risk management plans, which outline strategies for minimizing the risk of adverse events associated with drugs. Reviewing and approving of protocol for clinical trial safety and contributing to the report of clinical trial safety. Staying up-to-date with the latest developments in drug safety, including new regulations and guidelines, to ensure that safety evaluations are conducted in accordance with the latest standards. Reviewing and evaluating the safety and efficacy of new drug candidates during the development and approval process. Participating in the design and conduct of clinical trials to ensure that safety and efficacy data are collected and analyzed appropriately. Collaborating with other departments within the company, such as research and development, regulatory affairs, and marketing, to ensure that safety and efficacy data are communicated effectively to internal and external stakeholders. Contributing to the preparation of regulatory submissions and responding to questions from regulatory agencies regarding the safety and efficacy of drugs. Providing medical expertise and guidance to other members of the company, such as sales and marketing teams, to ensure that the appropriate safety information is communicated to healthcare professionals and patients. Participating in ongoing safety surveillance programs to monitor the safety of drugs once they are on the market. Being responsible for the overall safety of the drug, from preclinical development to post-approval. Education & Experience Bachelor s or Master s degree in Medical or Dental Sciences Previous experience that provides the knowledge, skills, and abilities to perform the job (3+ years ). Experience working in the pharmaceutical/CRO industry preferred Knowledge, Skills and Abilities Excellent technical data interpretation skills Strong understanding of Medical Sciences Excellent interpersonal skills including problem solving Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Significant knowledge of global, regional, national and other document development guidelines In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. Great judgment and decision-making skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Ability and desire to work in a team-oriented environment. Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner Possesses a collaborative, results-driven style. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines Other requirements As may be required from time to time the incumbent may be required to working slots catering to different time zones Apply Online First Name Last Name A valid email address is required. United States United Kingdom Albania (Shqip ri) American Samoa Antigua and Barbuda Austria ( sterreich) Azerbaijan (Az rbaycan) Belgium (Belgi ) Benin (B nin) Bosnia and Herzegovina ( ) Brazil (Brasil) British Indian Ocean Territory British Virgin Islands Burkina Faso Burundi (Uburundi) Cameroon (Cameroun) Cape Verde (Kabu Verdi) Caribbean Netherlands Cayman Islands Central African Republic (R publique centrafricaine) Chad (Tchad) Christmas Island Cocos (Keeling) Islands Congo (DRC) (Jamhuri ya Kidemokrasia ya Kongo) Congo (Republic) (Congo-Brazzaville) Cook Islands Costa Rica C te d Ivoire Croatia (Hrvatska) Cura ao Czech Republic ( esk republika) Denmark (Danmark) Dominican Republic (Rep blica Dominicana) El Salvador Equatorial Guinea (Guinea Ecuatorial) Estonia (Eesti) Falkland Islands (Islas Malvinas) Faroe Islands (F royar) Finland (Suomi) French Guiana (Guyane fran aise) French Polynesia (Polyn sie fran aise) Germany (Deutschland) Ghana (Gaana) Greenland (Kalaallit Nunaat) Guinea (Guin e) Guinea-Bissau (Guin Bissau) Hong Kong ( ) Hungary (Magyarorsz g) Iceland ( sland) Isle of Man Italy (Italia) Latvia (Latvija) Lithuania (Lietuva) Macedonia (FYROM) ( ) Madagascar (Madagasikara) Marshall Islands Mauritius (Moris) Mexico (M xico) Moldova (Republica Moldova) Montenegro (Crna Gora) Mozambique (Mo ambique) Myanmar (Burma) ( ) Namibia (Namibi ) Netherlands (Nederland) New Caledonia (Nouvelle-Cal donie) New Zealand Niger (Nijar) Norfolk Island North Korea ( ) Northern Mariana Islands Norway (Norge) Panama (Panam ) Papua New Guinea Peru (Per ) Poland (Polska) Puerto Rico R union (La R union) Romania (Rom nia) Saint Barth lemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Martin (Saint-Martin (partie fran aise)) Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon) Saint Vincent and the Grenadines San Marino S o Tom and Pr ncipe (S o Tom e Pr ncipe)