Senior Medical Writing Consultant

Overview Job Description The Senior Pharmacovigilance (PV) Physician I is responsible for medical review of ICSRs, writing and/or reviewing signal detection reports, writing and/or reviewing aggregate reports (DSURS, PSURS, PBRERs, PADERS), reviewing risk management reports (RMPs) and mentoring junior PV Physicians. The Senior PV Physician I is also expected to support the QPPV in medical aspects and safety issues as may be required by Company or Client. For the Client (may include but is not limited to the following): To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment. To complete the adverse event tracker for all ICSRs reports To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues To review and approve literature screening search strategy To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings To cooperate in the preparation of and provide input in Risk Management Plans Supporting/to lead the preparation of responses to regulatory authority requests Can act as EEA QPPV and/or Deputy for up to 2 clients if required. To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, ACOs or Annual Safety Reports. To act as Company Lead in a specific pharmacovigilance area requiring medical input (e.g., for preparation of reference safety information – Company Core Data Sheet) Actively participate in the Drug Safety Review Committee - signal detection and risk evaluation process for Client company medicinal products in the product life cycle. For the Company (may include but is not limited to the following): To support the preparation of PV procedures To provide training and mentoring of junior PV Physicians To provide medical advice and input to project teams on a daily basis Continuously working on the development of the procedures on the company level Preparing or contributing to the preparation of signalling related company procedures The Senior PV Physician will support the Director of Projects, as well as the QPPV, on a day to day basis as needed Supporting the Medical Director in training and mentoring on signalling activities Qualifications The PV Physician should be medically qualified as a physician Previous experience in pharmacovigilance Ability to review different aggregate report types including PBRERs and DSURs Expertise in signal detection activities is essential Excellent interpersonal skills Ability to plan, organise, prioritise and execute multiple tasks Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork Communication skills Presentation skills English - advanced (spoken, written) Advanced literacy (MS Office) Additional Information Why PrimeVigilance We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships Come and join us in this exciting journey to make a positive impact in patient's lives.