{"id":2754265,"url":"https://alion.io/job/biocryst-product-safety-associate-postmarketing-contract","title":"Product Safety Associate - Postmarketing (Contract)","company":{"id":1943951,"name":"BioCryst®","domain":"biocryst.com","url":"https://alion.io/company/biocryst","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Administrative","role_family":"Administrative","seniority":"junior","employment_type":"contractor","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":40000,"max_usd":68000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":348},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-10-15T00:00:00Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-11-05T15:40:46Z","board_verified":true,"closed_at":null,"days_open":21,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":21},"description":"JOB SUMMARY:\nThe ideal candidate is responsible for supporting postmarketing safety operations through safety mailbox management, adverse event (AE) case processing support, vendor and license partner oversight activities, and case reconciliation processes. This role serves as a key operational resource for the intake, triage, tracking, and organization of safety information received from global sources, ensuring the timely routing and processing of adverse event reports.\nThe Product Safety Associate supports case owners with case follow-up and query management activities, assists with postmarketing case data entry during periods of increased workload, and performs reconciliation activities with vendors and license partners. The role also supports partner oversight administration, maintains safety documentation, and contributes to inspection readiness and compliance with global pharmacovigilance requirements.\nESSENTIAL DUTIES & RESPONSIBILITIES:\nMonitors the electronic safety mailbox, including identifying, triaging, tracking, routing, and filing postmarketing safety information received from internal and external sources.\nBooks in and tracks postmarketing adverse event reports received from global sources.\nSupports case owners with adverse event case processing activities, including case follow-up and management of outstanding case queries.\nAssists with follow-up activities involving reporters, vendors, and license partners to obtain complete and accurate case information.\nAssists with data entry of postmarketing adverse event cases into the safety database in accordance with departmental data entry guidelines and procedures during periods of increased workload or high case volume.\nCoordinates quality control and medical review activities with the appropriate GDSP team members and Medical Directors.\nPerforms adverse event and case exchange reconciliation activities with BioCryst vendors and license partners, including tracking, investigation, and resolution of reconciliation discrepancies.\nMaintains reconciliation trackers and supporting documentation to ensure complete and accurate records of reconciliation activities.\nEnsures the filing and maintenance of adverse event information, reconciliation records, and other safety documentation received from BioCryst vendors and license partners in approved departmental repositories.\nSupports vendor and license partner oversight activities, including maintaining project-specific Excel trackers, developing and distributing meeting agendas, attending safety-related meetings and teleconferences, documenting key discussions and decisions, and preparing and distributing meeting minutes.\nTracks vendor and license partner commitments, action items, and deliverables to support oversight activities and ensure timely follow-up.\nContributes to inspection readiness activities through the maintenance of accurate, complete, and audit-ready safety documentation.\nMaintains knowledge of current global pharmacovigilance regulations, guidelines, and Good Pharmacovigilance Practices (GVP).\nPerforms additional operational support activities as assigned.\nEXPERIENCE & QUALIFICATIONS:\nBachelor's degree in a scientific discipline or an equivalent combination of education and relevant experience.\nMinimum of 2 years of experience in pharmaceutical, biotechnology, healthcare, or related industry, with at least 1 year of pharmacovigilance or drug safety experience preferred.\nExperience managing shared mailboxes, tracking systems, operational workflows, and documentation preferred.\nExperience supporting vendor oversight, license partner interactions, or reconciliation activities preferred.\nFamiliarity with adverse event case processing and postmarketing pharmacovigilance activities preferred.\nExperience working with a safety database (e.g., Argus) preferred.\nProficiency in Microsoft Office applications, including Outlook, Excel, Word, and Teams.\nHigh degree of accuracy and attention to detail.\nStrong organizational skills with the ability to manage multiple priorities and meet deadlines.\nEffective oral and written communication skills.\nAbility to work independently while collaborating effectively within a cross-functional environment.\nKnowledge of international postmarketing adverse event reporting requirements and Good Pharmacovigilance Practices (GVP) preferred.\nAbility to successfully function in a rapidly changing environment.\nThe statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.\nBioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.","description_format":"text","description_chars":5216,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Drug Discovery","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-17T01:12:26Z"}],"visa":[],"liveness":{"score":58,"band":"ok","label":"Likely open","p_open":1,"p_active":0.778,"p_room":0.75,"age_days":21,"expected_fill_days":25,"reasons":["conf:1","win:late","comp:junior"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/biocryst-product-safety-associate-postmarketing-contract","json_url":"https://alion.io/job/biocryst-product-safety-associate-postmarketing-contract.json","meta":{"generated_at":"2026-11-05T19:05:58Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":25618,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1943951},"rest":"https://alion.io/mcp/rest/get_company?id=1943951"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbiocryst-product-safety-associate-postmarketing-contract"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fbiocryst-product-safety-associate-postmarketing-contract"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fbiocryst-product-safety-associate-postmarketing-contract"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/biocryst-product-safety-associate-postmarketing-contract\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbiocryst-product-safety-associate-postmarketing-contract"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2754265}},{"tool":"search_jobs","arguments":{"company":"biocryst.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2754265},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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