Director, Pharmacovigilance (PV) Scientist
About the position Responsibilities • Work collaboratively with the medical monitor for timely review of SAEs, the development of analysis of similar events, and procurement of required follow-up information • Ensure that all SAEs are reviewed, processed, and expedited in accordance with global regulations • Project lead for signaling for assigned products including facilitation of cross-functional Safety Management Committee meetings including setting agendas, creating materials, presenting to the committee, and all associated documentation • Provide PV subject matter expertise in all areas of clinical development including core study document development and maintenance (CRFs, ICF, protocols, IBs), regulatory requests for information, and safety crisis management • Project lead and author on the annual Developmental Safety Update Reports • Development and/or support of standard operating procedures (SOPs) Requirements • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare 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 complex clinical /pharmaceutical information and safety data • Experience in the preparation and authoring of pre- 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 collaborative 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 Nice-to-haves • Experience working on BLA/MAA filings is preferred Benefits • Annual performance bonus • Equity • Full range of benefits • Other incentive compensation plans Apply tot his job