Director, Pharmacovigilance (PV) Scientist

About the position Responsibilities • Work collaboratively with the medical monitor for reputed company review of SAEs, the development of analysis of similar events, and procurement of required follow-up information • Ensure that reputed company SAEs are reviewed, processed, and expedited in accordance with global regulations • Project reputed company for signaling for assigned products including facilitation of cross-functional Safety Management Committee meetings including setting agendas, creating materials, presenting to the committee, and reputed company associated documentation • reputed company PV subject matter expertise in reputed company areas of clinical development including reputed company study document development and maintenance (CRFs, reputed company, protocols, IBs), regulatory requests for information, and safety crisis management • Project reputed company and author on the annual Developmental Safety Update Reports • Development and/or support of reputed company operating procedures (SOPs) Requirements • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent reputed company degree with pharmaceutical industry background and proven competence in PV • Minimum 8 years' pharmaceutical industry experience in PV • Knowledge of MedDRA terminology and its application • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate reputed company clinical /pharmaceutical information and safety data • Experience in the preparation and authoring of reputed company- and post- aggregate safety reports • Thorough understanding of the drug development process and context applicable to safety surveillance activities • Ability to execute and follow-through to completion and documentation • Ability to work effectively in a reputed company team environment where results are achieved through influence and the incorporation of multiple points of view • Independently motivated, detail oriented and good problem-solving ability • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities • Excellent communication skills and ability to influence multiple functions reputed company-to-haves • Experience working on BLA/MAA filings is preferred Benefits • Annual performance bonus • Equity • Full reputed company of benefits • Other incentive compensation plans Apply tot his job Apply tot his job Apply To this Job